Legend:
"+" means combination product, both fixed-dose combination (co-formulated) and co-packaged product (i.e. co-blister)
[A+B] + C means A and B are in a fixed-dose formulation and C is co-packaged
"*" refers to products approved by both WHO Prequalification Programme and US FDA
USFDA1 approved by US FDA; USFDA2 tentatively approved by US FDA; EMEA Art 58 - approved by EMEA according to Article 58
Note: For information about the listing of prequalified products and the alternative approval procedure, please see: General information
| Therapeutic area | INN | Formulation and strength | Applicant | Manufacturing site | Packaging | Reference no. | Date of PQ | Status |
|---|---|---|---|---|---|---|---|---|
| DI | Zinc (as sulfate monohydrate) | Dispersible tablets 20mg | Laboratoires Pharmaceutiques Rodael, France | Route de Socx, Bierne, France | Alu/PVDC/PVC blister 10 x 10 | DI002 | 04-Dec-2012 | |
| HIV | [Tenofovir disoproxil fumarate + Lamivudine] + Atazanavir (as sulfate) + Ritonavir | Tablets + Capsules + Tablets [300mg + 300mg] + 300mg + 100mg | Mylan Laboratories Ltd | Sinnar, Nashik District, Maharashtra, India | Alu/Alu blister (1+1+1) per co-packed blister, 3 blisters in a carton | HA512 | 28-Nov-2011 | |
| HIV | [Tenofovir disoproxil fumarate + Lamivudine] + Nevirapine | Tablets (co-packaged) [300mg + 300mg] + 200mg | Mylan Laboratories Ltd | Mylan Laboratories Ltd, Sinnar, Nashik District, Maharashtra, India; Mission Vivacare Ltd, Pithampur, Dhar, M.P., India; Waluj, Aurangabad, Maharashtra; Inda | Alu/Alu blister: (1+2) per blister, 3, 10 blisters in a carton | HA501* | 31-Mar-2011 | |
| HIV | Abacavir | Tablets 300mg | ViiV HealthCare | Glaxo Operations UK, Ltd, Ware, Herthfordshire, UK; GSK, Poznan (packaging and release), Poland | Blister 60 | HA106 | 20-Mar-2002 | |
| HIV | Abacavir | Tablets 300mg | Ranbaxy Laboratories Ltd | Paonta Sahib, Himachal Pradesh, India | HDPE bottle 60; Blister 6 x 10 | HA322 | 25-Jul-2008 | |
| HIV | Abacavir | Tablets 300mg | Cipla Ltd | Patalganga, India | HDPE bottle 60 | HA371* | 23-Apr-2008 | |
| HIV | Abacavir | Tablets 300mg | Mylan Laboratories Ltd | Sinnar, Nashik District, Maharashtra, India | HDPE bottle 60; Blister 6 x 10 | HA393* | 25-Jul-2008 | |
| HIV | Abacavir | Oral solution 20mg/ml | ViiV HealthCare | Mississauga, Ontario, Canada | HDPE bottle 240ml | HA107 | 20-Mar-2002 | |
| HIV | Abacavir (as sulfate) | Tablets 60mg | Mylan Laboratories Ltd | Sinnar, Nashik District, Maharashtra, India | HDPE bottle 60 | HA435* | 26-Oct-2009 | |
| HIV | Abacavir (as sulfate) | Tablets 300mg | Strides Arcolab Limited | Bangalore, India | Alu/PVC blister 6x10; HDPE bottle 60 | HA494* | 22-Dec-2011 | |
| HIV | Abacavir (as sulfate) | Oral solution 20mg/ml | Cipla Ltd | Verna, Goa, India | HDPE bottle 100ml, 240ml | HA382 | 11-Nov-2009 | |
| HIV | Abacavir (as sulfate) | Oral solution 20mg/ml | Meditab Specialities Pvt Ltd | Satara, Maharashtra, India | PET 100ml | HA453 | 02-May-2012 | |
| HIV | Abacavir (as sulfate) | Oral solution 20mg/ml | Hetero Labs Limited | Hyderabad, Andhra Pradesh, India | HDPE bottle 240ml | HA493 | 01-Nov-2012 | |
| HIV | Abacavir (as sulfate) | Dispersible tablets 60mg | Cipla Ltd | Patalganga, India | HDPE bottle 60 | HA488 | 20-Aug-2010 | |
| HIV | Abacavir (as sulfate) + Lamivudine | Tablets 60mg + 30mg | Mylan Laboratories Ltd | Sinnar, Nashik District, Maharashtra, India | HDPE bottle 30, 60; Triple laminated bag, 7000 (USFDA) | HA456* | 26-Oct-2009 | |
| HIV | Abacavir (as sulfate) + Lamivudine + Zidovudine | Tablets 60mg + 30mg + 60mg | Mylan Laboratories Ltd | Sinnar, Nashik District, Maharashtra, India | HDPE bottle 60 | HA436 | 25-May-2009 | |
| HIV | Abacavir (as sulfate) + Lamivudine + Zidovudine | Tablets 300mg + 150mg + 300mg | Mylan Laboratories Ltd | Sinnar, Nashik District, Maharashtra, India | HDPE bottle 60 | HA505* | 28-Nov-2011 | |
| HIV | Abacavir + Lamivudine + Zidovudine | Tablets 300mg + 150mg + 300mg | Ranbaxy Laboratories Ltd | Paonta Sahib, Himachal Pradesh, India | HDPE bottle 60 | HA324 | 07-Mar-2008 | |
| HIV | Abacavir + Lamivudine + Zidovudine | Tablets 300mg + 150mg + 300mg | ViiV HealthCare | Glaxo Operations UK, Ltd, Ware, Hertfordshire, UK; GSK, Poznan (packaging and release), Poland | Blister 40, 60; HDPE bottle 60 | HA111 | 20-Mar-2002 | |
| HIV | Atazanavir | Capsules 150mg | Bristol-Myers Squibb | Evansville, Indianna, USA; Mount Vernon, Indianna (primary packaging), USA | HDPE bottle 60 | HA421 | 07-Mar-2008 | |
| HIV | Atazanavir (as sulfate) | Capsules 300mg | Mylan Laboratories Ltd | Sinnar, Nashik District, Maharashtra, India; Waluj, Aurangabad, Maharashtra, India | HDPE bottle 30, 100 | HA477* | 25-Oct-2010 | |
| HIV | Atazanavir (as sulfate) | Capsules 150mg | Mylan Laboratories Ltd | Sinnar, Nashik District, Maharashtra, India; Waluj, Aurangabad, Maharashtra, India | HDPE bottle 30, 100 | HA478* | 25-Oct-2010 | |
| HIV | Atazanavir (as sulfate) + Ritonavir | Tablets 300mg + 100mg | Mylan Laboratories Ltd | Sinnar, Nashik District, Maharashtra, India | HDPE bottle 30; HDPE bottle 90, 120 (USFDA) | HA507* | 28-Nov-2011 | |
| HIV | Azithromycin | Film-coated tablets 500mg | HEC Pharm GmbH | Sunshine Lake Pharma Co Ltd, Dongguan, Guangdong, China | Al/PVC/PVDC blister 3 | HA556 | 02-Nov-2012 | |
| HIV | Ceftriaxone | Powder for injection 500mg | Roche | Basel, Switzerland | Glass vials 5ml | HA137 | 29-May-2002 | |
| HIV | Ceftriaxone | Powder for injection 250mg | Roche | Basel, Switzerland | Glass vials 5ml | HA138 | 29-May-2002 | |
| HIV | Ciprofloxacin | Tablets 750mg | Laboratorios Cinfa S.A. | Navarra, Spain | Blister 10 | HA001 | 20-Mar-2002 | |
| HIV | Ciprofloxacin | Tablets 750mg | Cipla Ltd | Kurkumbh, India; Goa, India | Blister 10 | HA059 | 20-Mar-2002 | |
| HIV | Ciprofloxacin | Tablets 500mg | Laboratorios Cinfa S.A. | Navarra, Spain | Blister 10, 20 | HA002 | 20-Mar-2002 | |
| HIV | Ciprofloxacin | Tablets 500mg | Cipla Ltd | Kurkumbh, India; Goa, India | Blister 10 | HA058 | 20-Mar-2002 | |
| HIV | Ciprofloxacin | Tablets 250mg | Laboratorios Cinfa S.A. | Navarra, Spain | Blister 10, 20 | HA003 | 20-Mar-2002 | |
| HIV | Ciprofloxacin | Tablets 100mg | Cipla Ltd | Kurkumbh, India; Goa, India | Blister 10 | HA056 | 20-Mar-2002 | |
| HIV | Ciprofloxacin | Tablets 250mg | Cipla Ltd | Kurkumbh, India; Goa, India |
Blister 10 | HA057 | 20-Mar-2002 | |
| HIV | Darunavir (as ethanolate) | Tablets 75mg | Janssen-Cilag International NV, Belgium | Janssen Ortho LLC, Gurabo, Puerto Rico, United States (Manufacturing and release testing); Janssen-Cilag SpA, Latina, Italy (Testing and final QC release and packaging) | HDPE bottle 480 | HA529 | 11-Sep-2012 | |
| HIV | Darunavir (as ethanolate) | Tablets 150mg | Janssen-Cilag International NV, Belgium | Janssen Ortho LLC, Gurabo, Puerto Rico, United States (Manufacturing and release testing); Janssen-Cilag SpA, Latina, Italy (Testing and final QC release and packaging) | HDPE bottle 240 | HA530 | 11-Sep-2012 | |
| HIV | Darunavir (as ethanolate) | Film-coated tablets 600mg | Janssen-Cilag International NV, Belgium | Janssen Ortho LLC, Gurabo, Puerto Rico, USA (manufacturing and release testing); Janssen-Cilag SpA, Latina, Italy (packaging, testing and QC release); Pharmacare Limited, Korsten, Port Elizabeth, South Africa (QC release) | HDPE bottle 60 | HA531 | 04-Dec-2012 | |
| HIV | Diazepam | Tablets 5mg | Apotex Inc. | Toronto, Ontario, Canada | HDPE bottle 100, 1000 | HA560 | 16-Nov-2012 | |
| HIV | Diazepam | Tablets 2mg | Apotex Inc. | Toronto, Ontario, Canada | HDPE bottle 100, 1000 | HA559 | 16-Nov-2012 | |
| HIV | Didanosine | Tablets 50mg | Bristol-Myers Squibb | Emcure Pharmaceuticals USA, New Jersey, USA (Manufacturing and primary packaging); Bristol-Myers Squibb, Anagni (Frosinone), Italy (Secondary packaging, testing and batch release) | HDPE bottle 60 | HA066 | 20-Mar-2002 | |
| HIV | Didanosine | Tablets 25mg | Bristol-Myers Squibb | Emcure Pharmaceuticals USA, New Jersey, USA (Manufacturing and primary packaging); Bristol-Myers Squibb, Anagni (Frosinone), Italy (Secondary packaging, testing and batch release) | HDPE bottle 60 | HA065 | 20-Mar-2002 | |
| HIV | Didanosine | Tablets 150mg | Bristol-Myers Squibb | Emcure Pharmaceuticals USA, New Jersey, USA (Manufacturing and primary packaging); Bristol-Myers Squibb, Anagni (Frosinone), Italy (Secondary packaging, testing and batch release) | HDPE bottle 60 | HA068 | 20-Mar-2002 | |
| HIV | Didanosine | Tablets 100mg | Bristol-Myers Squibb | Emcure Pharmaceuticals USA, New Jersey, USA (Manufacturing and primary packaging); Bristol-Myers Squibb, Anagni (Frosinone), Italy (Secondary packaging, testing and batch release) | HDPE bottle 60 | HA067 | 20-Mar-2002 | |
| HIV | Didanosine | Powder for oral solution 2g | Bristol-Myers Squibb | Mount Vernon, Indiana, USA; Anagni (Secondary packaging and batch release), Italy | Glass bottle 2g | HA332 | 23-May-2006 | |
| HIV | Didanosine | Delayed release capsules 400mg | Mylan Laboratories Ltd | Sinnar, Nashik District, Maharashtra, India | HDPE bottle 30 | HA474* | 01-Sep-2011 | |
| HIV | Didanosine | Delayed release capsules 250mg | Mylan Laboratories Ltd | Sinnar, Nashik District, Maharashtra, India | HDPE bottle 30 | HA473* | 01-Sep-2011 | |
| HIV | Didanosine | Delayed release capsules 200mg | Mylan Laboratories Ltd | Sinnar, Nashik District , Maharashtra, India | HDPE bottle 30 | HA472* | 01-Sep-2011 | |
| HIV | Didanosine | Delayed release capsules 125mg | Mylan Laboratories Ltd | Sinnar, Nashik District, Maharashtra, India | HDPE bottle 30 | HA471* | 01-Sep-2011 | |
| HIV | Didanosine | Capsules 400mg | Bristol-Myers Squibb | Mount Vernon, Indiana, USA; Anagni (Primary and secondary packaging and batch release), Italy | Blister 30 | HA331 | 23-May-2006 | |
| HIV | Didanosine | Capsules 250mg | Bristol-Myers Squibb | Mount Vernon, Indiana, USA; Anagni (Primary and secondary packaging and batch release), Italy | Blister 30 | HA330 | 23-May-2006 | |
| HIV | Efavirenz | Tablets 600mg | Hetero Labs Limited | Hyderabad, Andhra Pradesh, India; Mahaboob Nagar, Andhra Pradesh, India | HDPE bottle 30, 250 | HA399* | 01-Jul-2009 | |
| HIV | Efavirenz | Tablets 600mg | Mylan Laboratories Ltd | Sinnar, Nashik District, Maharashtra, India | HDPE bottle 30; Blister packs 10 | HA403* | 25-Jul-2008 | |
| HIV | Efavirenz | Tablets 600mg | Macleods Pharmaceuticals Ltd | Solan, Himachal Pradesh, India | HDPE bottle 30 | HA506* | 04-Dec-2012 | |
| HIV | Efavirenz | Tablets 50mg | Merck Sharp & Dohme Limited | South Granville, NSW - Australia; BN Haarlem (packager, responsible for batch release in the EU) - Netherlands |
HDPE bottle 30 | HA427 | 14-May-2008 | |
| HIV | Efavirenz | Tablets 200mg | Strides Arcolab Limited | Anekal Taluk, Bangalore, India | HDPE bottle 90 | HA389* | 24-Feb-2009 | |
| HIV | Efavirenz | Tablets 200mg | Merck Sharp & Dohme Limited | South Granville, NSW - Australia; BN Haarlem (packager, responsible for batch release in the EU) - Netherlands |
HDPE bottle 90 | HA428 | 14-May-2008 | |
| HIV | Efavirenz | Dispersible tablets 100mg | Ranbaxy Laboratories Ltd | S.A.S. Nagar (Mohali), Punjab, India | HDPE bottle 30 | HA509 | 02-May-2012 | |
| HIV | Efavirenz | Capsules 200mg | Cipla Ltd | Goa, India | HDPE bottle 90; 1000(USFDA) | HA438* | 14-Dec-2010 | |
| HIV | Efavirenz | Tablets 600mg | Ranbaxy Laboratories Ltd | Paonta Sahib, Himachal Pradesh, India | Blister 30; HDPE bottle 30 | HA306 | 23-May-2006 | |
| HIV | Efavirenz | Tablets 600mg | Merck Sharp & Dohme | Bristol-Myers Squibb Pharma, Manati, Puerto Rico; Merck Sharp & Dohme Australia Pty. Ltd, South Granville, Australia; Merck Sharp & Dohme, BV Haarlem, The Netherlands; Zhejiang Huahai Pharmaceutical Co., Ltd, Zhejiang, China | HDPE bottle 30 | HA337 | 23-May-2006 | |
| HIV | Efavirenz | Tablets 600mg | Cipla Ltd | Goa, India; Himachal Pradesh, India; Quality Chemical Industries Ltd, Kampala, Uganda; Meditab Specialities Pvt Ltd, Kundaim, Goa, India | HDPE bottle 30; HDPE bottle 500 (USFDA) | HA352* | 16-Dec-2008 | |
| HIV | Efavirenz | Tablets 600mg | Strides Arcolab Limited | Bangalore, India | HDPE bottle 30 | HA390* | 24-Feb-2009 | |
| HIV | Efavirenz | Oral solution 30mg/ml | Merck Sharp & Dohme | Patheon, Ontario, Canada; Haarlem, The Netherlands | HDPE bottle 180ml | HA338 | 23-May-2006 | |
| HIV | Efavirenz | Capsules 50mg | Merck Sharp & Dohme | Manati, Puerto Rico; Haarlem, The Netherlands |
HDPE bottle 30 | HA335 | 01-Mar-2006 | |
| HIV | Efavirenz | Capsules 200mg | Ranbaxy Laboratories Ltd | Paonta Sahib, Himachal Pradesh, India | Blister 90; HDPE bottle 90 | HA305 | 23-May-2006 | |
| HIV | Efavirenz | Capsules 200mg | Merck Sharp & Dohme | Manati, Puerto Rico; Haarlem, The Netherlands |
HDPE bottle 90 | HA336 | 01-Mar-2006 | |
| HIV | Efavirenz + [Lamivudine + Stavudine] | Tablets 600mg +Tablets [150mg + 40mg] | Ranbaxy Laboratories Ltd | Paonta Sahib, Himachal Pradesh, India | Alu/Alu blister 2+1; Cardboard box 30+15 | HA358 | 30-Aug-2007 | |
| HIV | Efavirenz + [Lamivudine + Stavudine] | Tablets 600mg + Tablets [150mg + 30mg] | Ranbaxy Laboratories Ltd | Paonta Sahib, Himachal Pradesh, India | Alu/Alu blister 2+1; Cardboard box 30+15 | HA357 | 30-Aug-2007 | |
| HIV | Efavirenz + [Lamivudine + Zidovudine] | Tablets 600mg + Tablets [150mg + 300mg] | Ranbaxy Laboratories Ltd | Paonta Sahib, Himachal Pradesh, India | Alu/Alu blister 2+1; Cardboard box 30+15 | HA356 | 30-Aug-2007 | |
| HIV | Efavirenz + Emtricitabine + Tenofovir | Tablets 600mg + 200mg + 300mg | Merck Sharp & Dohme | Patheon Inc., Mississauga, Ontario, Canada; Merck Sharp & Dohme, BV Haarlem, (Packaging & batch release site), The Netherlands |
HDPE bottle 30 | HA413 | 21-Dec-2007 | |
| HIV | Efavirenz + Emtricitabine + Tenofovir disoproxil fumarate | Tablets 600mg + 200mg + 300mg | Cipla Ltd | Goa, India | HDPE bottle 30 | HA500 | 08-Dec-2011 | |
| HIV | Efavirenz + Emtricitabine +Tenofovir disoproxil fumarate | Tablets 600mg + 200mg + 300mg | Mylan Laboratories Ltd | Sinnar, Nashik District, Maharashtra, India | HDPE bottle 30 | HA444 | 25-Oct-2010 | |
| HIV | Efavirenz + Lamivudine + Tenofovir disoproxil fumarate | Tablets 600mg + 300mg + 300mg | Mylan Laboratories Ltd | Sinnar, Nashik District, Maharashtra, India | HDPE bottle 30 | HA466 | 25-Oct-2010 | |
| HIV | Emtricitabine | Capsules 200mg | Cipla Ltd | Goa, India | HDPE bottle 30 | HA418 | 01-Sep-2011 | |
| HIV | Emtricitabine | Capsules 200mg | Mylan Laboratories Ltd | Sinnar, Nashik District, Maharashtra, India | HDPE bottle 30; HDPE bottle 100; (USFDA) Blister 2 X 10, 3 X 10 (USFDA) | HA451* | 29-Apr-2010 | |
| HIV | Emtricitabine + Tenofovir | Tablets 200mg + 300mg | Gilead Sciences, Inc. | Altana Pharma, Oranienburg GmbH, Germany; Patheon Inc., Mississauga, Ontario, Canada; Aspen Pharmacare, OSD Facility, Korsten, Port Elizabeth, South Africa |
HDPE bottle 30 | HA343 | 23-May-2006 | |
| HIV | Emtricitabine + Tenofovir disoproxil fumarate | Tablets 200mg + 300mg | Mylan Laboratories Ltd | Sinnar, Nashik District, Maharashtra, India | HDPE bottle 30, 100; Blister 3 x 10; Blister 10 (USFDA) | HA417* | 20-Aug-2010 | |
| HIV | Emtricitabine + Tenofovir disoproxil fumarate | Tablets 200mg + 300mg | Cipla Ltd | Goa, India | HDPE bottle 30 | HA439 | 05-Oct-2011 | |
| HIV | Etravirine | Tablets 100mg | Janssen-Cilag International NV, Belgium | Janssen-Cilag SpA, Latina, Italy (Manufacturing, packaging, release testing and final QC release) | HDPE bottle 120 | HA532 | 11-Sep-2012 | |
| HIV | Fluconazole | Capsules 50mg | Cipla Ltd | Kurkumbh, India | Blister 10 | HA207 | 13-Jul-2004 | |
| HIV | Fluconazole | Capsules 200mg | Cipla Ltd | Kurkumbh, India | Blister 10 | HA209 | 13-Jul-2004 | |
| HIV | Fluconazole | Capsules 150mg | Cipla Ltd | Kurkumbh, India | Blister 10 | HA208 | 13-Jul-2004 | |
| HIV | Ganciclovir | Powder for injection 500mg | F.Hoffman-La Roche | Basel, Switzerland | Vials, glass, 10ml | HA134 | 29-May-2002 | |
| HIV | Ganciclovir (as sodium salt) | Powder for injection 500mg | Hainan Poly Pharm Co Ltd | Haikou, Hainan, China | Glass vial 10ml | HA515 | 20-Dec-2012 | |
| HIV | Indinavir | Capsules 400mg | Hetero Labs Limited | Unit-III, Jeedimetla, Hyderabad, Andhra Pradesh, India | Alu/Alu strips 10 x 10; HDPE bottle 180 | HA151 | 29-May-2007 | |
| HIV | Indinavir | Capsules 400mg | Merck Sharp & Dohme | Elkton, Virginia, USA; | HDPE bottle 180 | HA334 | 23-May-2006 | |
| HIV | Indinavir (as sulfate) | Capsules 400mg | Ranbaxy Laboratories Ltd | Paonta Sahib, Himachal Pradesh, India | HDPE bottle 90, 180 | HA363 | 10-Nov-2009 | |
| HIV | Lamivudine | Tablets 30mg | Cipla Ltd | Goa, India | HDPE bottle 60 | HA502 | 04-Jul-2012 | |
| HIV | Lamivudine | Tablets 30mg | Micro Labs Limited | Verna, Goa, India | PVC/PVdC/Alu blister 10 x 10; HDPE bottle 60, 100, 500, 1000 | HA536 | 18-Feb-2013 | |
| HIV | Lamivudine | Tablets 300mg | Cipla Ltd | Goa, India | HDPE bottle 30, 60 | HA354 | 29-Sep-2010 | |
| HIV | Lamivudine | Tablets 300mg | Mylan Laboratories Ltd | Sinnar, Nashik District, Maharashtra, India | PVdC/PVC/Alu blister 6 x 10; HDPE bottle 60 | HA420* | 16-Dec-2008 | |
| HIV | Lamivudine | Tablets 300mg | Macleods Pharmaceuticals Ltd | Kachigam, Daman, India | HDPE bottle 30; PVC/PVdC/Alu Blister 3 x 10 | HA425* | 14-Dec-2010 | |
| HIV | Lamivudine | Tablets 150mg | ViiV HealthCare | Glaxo Operations UK, Ltd, Ware, Hertfordshire, UK; GSK, Poznan (packaging and release), Poland | HDPE bottle 60 | HA117 | 20-Mar-2002 | |
| HIV | Lamivudine | Tablets 150mg | Strides Arcolab Ltd | Anekal Taluk, Bangalore, India | Blister 10; HDPE bottle 60 | HA203* | 13-Jul-2004 | |
| HIV | Lamivudine | Tablets 150mg | Aspen Port Elizabeth (Pty) Ltd | Port Elizabeth, South Africa | Metallised lay flat pack, PP bottle 60 | HA282 | 01-Dec-2005 | |
| HIV | Lamivudine | Tablets 150mg | Ranbaxy Laboratories Ltd | Paonta Sahib, Himachal Pradesh, India | Blister 10; HDPE bottle 60 | HA290* | 11-Aug-2005 | |
| HIV | Lamivudine | Tablets 150mg | Cipla Ltd | Cipla Ltd, Goa, India; Meditab Specialties Pvt Ltd, Kundaim, Goa, India | HDPE bottle 30, 60 | HA353 | 29-Sep-2010 | |
| HIV | Lamivudine | Tablets 150mg | Macleods Pharmaceuticals Ltd | Kachigam, Daman, India | HDPE bottle 60; PVC/PVdC/Alu Blister 6 X 10 | HA424* | 14-Dec-2010 | |
| HIV | Lamivudine | Oral solution 10mg/ml | Cipla Ltd | Goa, India; Indore, SEZ, Pithampur, Dist Dhar (M.P.), India | PET bottle 100ml; HDPE bottle 240ml (USFDA) | HA053* | 20-Mar-2002 | |
| HIV | Lamivudine | Oral solution 10mg/ml | ViiV HealthCare | Mississauga, Ontario, Canada | HDPE bottle 240ml | HA128 | 20-Mar-2002 | |
| HIV | Lamivudine | Oral solution 10mg/ml | Macleods Pharmaceuticals Ltd | Solan, Himachal Pradesh, India | HDPE bottle 240ml | HA523 | 05-Feb-2013 | |
| HIV | Lamivudine | Film-coated tablets 150mg | Hetero Labs Limited | Hetero Labs Limited, Unit-III, Jeedimetla, Hyderabad, Andhra Pradesh, India; STADA-VN Joint Venture Co, Ltd, Duong Province, Vietnam | PVC/Alu Blisters 10 x 10; HDPE bottle 60; HDPE bottle 600 (USFDA) | HA153* | 29-May-2007 | |
| HIV | Lamivudine | Film-coated tablets 150mg | Mylan Laboratories Ltd | Sinnar, Nashik District, Maharashtra, India | HDPE bottle 60; Blister (PVdC/PVC/Alu) 10 | HA391* | 07-Mar-2008 | |
| HIV | Lamivudine | Dispersible tablets 30mg | Ranbaxy Laboratories Ltd | Paonta Sahib, Himachal Pradesh, India | HDPE bottle 60 | HA533 | 14-Sep-2012 | |
| HIV | Lamivudine + Nevirapine + Stavudine | Tablets 150mg + 200mg + 40mg | Mylan Laboratories Ltd | Sinnar, Nashik District, Maharashtra, India | HDPE bottle 60 | HA408 | 25-Jul-2008 | |
| HIV | Lamivudine + Nevirapine + Stavudine | Tablets 150mg + 200mg + 30mg | Mylan Laboratories Ltd | Sinnar, Nashik District, Maharashtra, India | HDPE bottle 60 | HA407 | 25-Jul-2008 | |
| HIV | Lamivudine + Nevirapine + Stavudine | Tablets 150mg + 200mg + 30mg | Varichem Pharmaceuticals (Pvt) Ltd | Harare, Zimbabwe | HDPE bottle 60 | HA482 | 14-Dec-2010 | |
| HIV | Lamivudine + Nevirapine + Stavudine | Dispersible tablets 60mg + 100mg + 12mg | Cipla Ltd | Goa, India | HDPE bottle 60; HDPE bottle 1000 (USFDA) | HA376* | 23-Apr-2008 | |
| HIV | Lamivudine + Nevirapine + Stavudine | Dispersible tablets 30mg + 50mg + 6mg | Cipla Ltd | Goa, India | HDPE bottle 60; HDPE bottle 1000 (USFDA) | HA375* | 23-Apr-2008 | |
| HIV | Lamivudine + Nevirapine + Stavudine | Tablets 150mg + 200mg + 40mg | Hetero Labs Limited | Jeedimetla, Hyderabad, Andhra Pradesh, India | Blister 10; HDPE bottle 60 | HA276 | 29-Sep-2005 | |
| HIV | Lamivudine + Nevirapine + Stavudine | Tablets 150mg + 200mg + 30mg | Ranbaxy Laboratories Ltd | Paonta Sahib, Himachal Pradesh, India | HDPE bottle 60 | HA300 | 11-Aug-2005 | |
| HIV | Lamivudine + Nevirapine + Stavudine | Tablets 150mg + 200mg + 30mg | Cipla Ltd | Patalganga, India; Goa, India; Himachal Pradesh, India; Cipla Ltd Indore, SEZ, Pithampur, Dist Dhar (M.P.), India |
HDPE bottle 60; HDPE bottle 30, 1000 (USFDA) | HA267* | 09-Aug-2004 | |
| HIV | Lamivudine + Nevirapine + Stavudine | Tablets 150mg + 200mg + 30mg | Hetero Labs Limited | Unit-III, Jeedimetla, Hyderabad, Andhra Pradesh, India; Unit-V, Mahaboob Nagar, Andhra Pradesh, India | HDPE bottle 60, 100, 500 | HA277* | 21-Dec-2005 | |
| HIV | Lamivudine + Nevirapine + Zidovudine | Tablets 150mg + 200mg + 300mg | Macleods Pharmaceuticals Ltd | Kachigam, Daman, India | HDPE bottle 60 | HA513* | 24-May-2012 | |
| HIV | Lamivudine + Nevirapine + Zidovudine | Tablets 150mg + 200mg + 300mg | Ranbaxy Laboratories Ltd | Paonta Sahib, Himachal Pradesh, India | HDPE bottle, 60; PVdC/PVC blister 10 | HA323 | 07-Mar-2008 | |
| HIV | Lamivudine + Nevirapine + Zidovudine | Tablets 150mg + 200mg + 300mg | Mylan Laboratories Ltd | Sinnar, Nashik District, Maharashtra, India; Waluj, Aurangabad, Maharashtra, India; Mission Vivacare Limited, Pithampur, Dhar, M.P., India; Shasun Pharmaceutical Ltd, Periyakalapet, Puducherry, India | PVC/PVdC/Alu blister 6 X 10; HDPE bottle 60 | HA426* | 24-Feb-2009 | |
| HIV | Lamivudine + Nevirapine + Zidovudine | Film-coated tablets 150mg + 200mg + 300mg | Cipla Ltd | Cipla Ltd, Goa, India; Cipla Ltd, Indore, SEZ, Pithampur, Dist Dhar (M.P.), India; Quality Chemical Industries Ltd, Kampala, Uganda; Cipla Ltd Baddi, Himachal Pradesh, India; Meditab Specialities Pvt Ltd, Kundaim, Goa, India | HDPE bottle 30, 60; HDPE bottle 500 (USFDA) | HA365* | 10-Mar-2009 | |
| HIV | Lamivudine + Nevirapine + Zidovudine | Dispersible tablets 30mg + 50mg + 60mg | Mylan Laboratories Ltd | Sinnar, Nashik District, Maharashtra, India; Waluj, Aurangabad, Maharashtra, India | HDPE bottle 60 | HA433* | 26-Oct-2009 | |
| HIV | Lamivudine + Nevirapine + Zidovudine | Tablets 150mg + 200mg + 300mg | Hetero Labs Limited | Unit-III, Jeedimetla, Hyderabad, Andhra Pradesh, India; Unit-V, Mahaboob Nagar, Andhra Pradesh, India | Blister 10; HDPE bottle 60 | HA275 | 23-May-2006 | |
| HIV | Lamivudine + Stavudine | Tablets 150mg + 40mg | Mylan Laboratories Ltd | Sinnar, Nashik Dsitrict, Maharashtra, India | HDPE bottle 60; Blister 10 (USFDA) | HA406* | 25-Jul-2008 | |
| HIV | Lamivudine + Stavudine | Tablets 150mg + 30mg | Cipla Ltd | Goa, India; Patalganga; India | HDPE bottle 60; HDPE bottle 30, 1000 (USFDA) | HA303* | 30-Aug-2007 | |
| HIV | Lamivudine + Stavudine | Tablets 150mg + 30mg | Strides Arcolab Ltd | Bangalore, India | HDPE bottle 60 | HA313 | 21-Dec-2007 | |
| HIV | Lamivudine + Stavudine | Tablets 150mg + 30mg | Mylan Laboratories Ltd | Sinnar, Nashik District, Maharashtra, India | HDPE bottle 60; Blister 10 (USFDA) | HA405* | 25-Jul-2008 | |
| HIV | Lamivudine + Stavudine | Dispersible tablets 60mg + 12mg | Cipla Ltd | Goa, India | Alu/Alu strip 14, HDPE bottle 30, 60; Blister 14, (USFDA) HDPE bottle 1000 (USFDA); | HA455* | 08-Feb-2011 | |
| HIV | Lamivudine + Stavudine | Dispersible tablets 30mg + 6mg | Cipla Ltd | Goa, India | Alu/Alu strip 14, HDPE bottle 30, 60; Blister 14 (USFDA), HDPE bottle 1000 (USFDA) | HA454* | 08-Feb-2011 | |
| HIV | Lamivudine + Stavudine | Tablets 150mg + 30mg | Ranbaxy Laboratories Ltd | Paonta Sahib, Himachal Pradesh, India | Blister 10; HDPE bottle 60 | HA302 | 11-Aug-2005 | |
| HIV | Lamivudine + Tenofovir disoproxil fumarate | Tablets 300mg + 300mg | Mylan Laboratories Ltd | Mylan Laboratories Ltd, Sinnar, Nashik District, Maharashtra, India; Mission Vivacare Ltd, Pithampur, Dhar, M.P., India; Waluj, Aurangabad, Maharashtra; Inda | HDPE bottle 30, 100 | HA414 | 30-Jun-2010 | |
| HIV | Lamivudine + Tenofovir disoproxil fumarate | Tablets 300mg + 300mg | Hetero Labs Limited | Jeedimetla, Hyderabad, Andhra Pradesh, India | HDPE bottle 30, 60; HDPE bottle 100, 500 (USFDA) | HA448* | 01-Sep-2011 | |
| HIV | Lamivudine + Tenofovir disoproxil fumarate | Tablets 300mg + 300mg | Cipla Ltd | Kurkumbh, India | HDPE bottle 30; 500(USFDA) | HA489* | 05-Oct-2011 | |
| HIV | Lamivudine + Tenofovir disoproxil fumarate | Tablets 300mg + 300mg | Ranbaxy Laboratories Ltd | Shasun Pharmaceutical Limited, Periyakalapet, Puducherry, India | HDPE bottle 30 | HA525 | 11-Sep-2012 | |
| HIV | Lamivudine + Zidovudine | Tablets 30mg + 60mg | Mylan Laboratories Ltd | Sinnar, Nashik District, Maharashtra, India | HDPE bottle 60 | HA437* | 25-May-2009 | |
| HIV | Lamivudine + Zidovudine | Tablets 150mg + 300mg | Universal Corporation Ltd | Kikuyu, Kenya | HDPE bottle 60 | HA490 | 21-Oct-2011 | |
| HIV | Lamivudine + Zidovudine | Tablets 150mg + 300mg | Strides Arcolab Ltd | Bangalore, India | HDPE bottle 60 | HA291* | 30-Jun-2006 | |
| HIV | Lamivudine + Zidovudine | Tablets 150mg + 300mg | Mylan Laboratories Ltd | Mylan Laboratories Ltd, Sinnar, Nashik District, Maharashtra, India; Mission Vivacare Ltd, Pithampur, Dhar M.P., India; Mylan Laboratories Ltd, Waluj, Aurangabad, Maharashtra, India | HDPE bottle 60, Blister 60; Blister 10 (USFDA) | HA392* | 23-Apr-2008 | |
| HIV | Lamivudine + Zidovudine | Tablets 150mg + 300mg | Varichem Pharmaceuticals (Pvt) Ltd | Harare, Zimbabwe | HDPE bottle 60 | HA402 | 29-Sep-2010 | |
| HIV | Lamivudine + Zidovudine | Tablets 150mg + 300mg | Macleods Pharmaceuticals Ltd | Kachigam, Daman, India | HDPE bottle 60; PVC/PVdC/Alu blister 6 x 10; 12 x 10(USFDA) | HA459* | 18-Oct-2011 | |
| HIV | Lamivudine + Zidovudine | Tablets 150mg + 300mg | Micro Labs Limited | Verna, Goa, India | HDPE bottle 30, 60, 90; PVDC/PVC/Alu blister 10x10 | HA485 | 25-Oct-2010 | |
| HIV | Lamivudine + Zidovudine | Dispersible tablets 30mg + 60mg | Ranbaxy Laboratories Ltd | Paonta Sahib, Himachal Pradesh, India | HDPE bottle 60 | HA463 | 29-Sep-2011 | |
| HIV | Lamivudine + Zidovudine | Tablets 150mg + 300mg | Cipla Ltd | Goa, India; Indore, SEZ, Pithampur, Dist Dhar (M.P.), India; Quality Chemical Industries Ltd, Kampala, Uganda; Cipla Ltd Baddi, Himachal Pradesh, India; Meditab Specialities Pvt Ltd, Kundaim, Goa, India | Blister 10, 14; HDPE bottle 60; HDPE bottle 1000 (USFDA) | HA060* | 30-Nov-2004 | |
| HIV | Lamivudine + Zidovudine | Tablets 150mg + 300mg | ViiV HealthCare | Glaxo Operations UK, Ltd, Ware, Hertfordshire, UK; GSK, Poznan (packaging and release), Poland | Blister 60; HDPE bottle 60 | HA110 | 20-Mar-2002 | |
| HIV | Lamivudine + Zidovudine | Tablets 150mg + 300mg | Hetero Labs Limited | Hyderabad, Andhra Pradesh, India | Blister 10, HDPE bottle 60; HDPE bottle 500 (USFDA) | HA152* | 23-May-2006 | |
| HIV | Lamivudine + Zidovudine | Tablets 150mg + 300mg | Ranbaxy Laboratories Ltd | Paonta Sahib, Himachal Pradesh, India | HDPE bottle 60; Alu/PA/PVC blister 10; PVdC/PVC blister 10 | HA286 | 11-Aug-2005 | |
| HIV | Lopinavir + Ritonavir | Tablets 200mg + 50mg | Abbott Laboratories | Ludwigshafen, Germany | HDPE bottle 120 | HA381 | 30-Oct-2006 | |
| HIV | Lopinavir + Ritonavir | Tablets 200mg + 50mg | Mylan Laboratories Ltd | Sinnar, Nashik District, Maharashtra, India | Alu/Alu blister 10 X 12; HDPE bottle 120; Blister 6 (USFDA) | HA411* | 19-Feb-2009 | |
| HIV | Lopinavir + Ritonavir | Tablets 200mg + 50mg | Abbott Laboratories | Ludwigshafen, Germany | HDPE bottle 120 | HA412 | 06-Jun-2007 | |
| HIV | Lopinavir + Ritonavir | Tablets 200mg + 50mg | Hetero Labs Limited | Hyderabad, Andhra Pradesh, India | HDPE bottle 60, 120; Alu/Alu blister 10; Alu/PVC/PVdC blister 10 | HA492 | 11-Jan-2013 | |
| HIV | Lopinavir + Ritonavir | Tablets 100mg + 25mg | Mylan Laboratories Ltd | Unit-8, Andhra Pradesh (for premix), India Sinnar, Nashik District, Maharashtra (for tablets), India | HDPE bottle 120 | HA429 | 25-May-2009 | |
| HIV | Lopinavir + Ritonavir | Tablets 100mg + 25mg | Abbott Laboratories | Ludwigshafen, Germany | HDPE bottle 60 | HA434 | 25-Jul-2008 | |
| HIV | Lopinavir + Ritonavir | Oral solution (80mg + 20mg)/ml | Abbott Laboratories | Queensborough, Kent, UK | PET bottle 60ml | HA098 | 20-Mar-2002 | |
| HIV | Lopinavir + Ritonavir | Capsules 133,3mg + 33,3mg | Abbott Laboratories | RP Scherer, Florida, USA | HDPE bottle 90 | HA097 | 20-Mar-2002 | |
| HIV | Nevirapine | Tablets 200mg | Cipla Ltd | Cipla Ltd, Goa, India; Meditab Specialties Pvt Ltd, Kundaim, Goa, India; Quality Chemical Industries Ltd, Kampala, Uganda | Blister 10; HDPE bottle 60; HDPE bottle 1000(USFDA) | HA039* | 20-Mar-2002 | |
| HIV | Nevirapine | Tablets 200mg | Hetero Labs Limited | Unit-III, Jeedimetla, Hyderabad, Andhra Pradesh, India | Blister 10; HDPE bottle 60; HDPE bottle 100, 500, 1000 (USFDA) | HA155* | 04-Jul-2003 | |
| HIV | Nevirapine | Tablets 200mg | Boehringer Ingelheim | Boehringer Ingelheim Pharma GmbH & Co, KG, Ingelheim, Germany; Boehringer Ingelheim Ellas A.E., Koropi, Greece | Blister 60 | HA187 | 28-Feb-2003 | |
| HIV | Nevirapine | Tablets 200mg | Strides Arcolab Ltd | Bangalore, India | HDPE bottle 60 | HA268* | 01-Apr-2005 | |
| HIV | Nevirapine | Tablets 200mg | Aspen Pharmacare | Port Elizabeth, South Africa | Blister 10 | HA280 | 23-May-2006 | |
| HIV | Nevirapine | Tablets 200mg | Ranbaxy Laboratories Ltd | Paonta Sahib, Himachal Pradesh, India | Blister 10; HDPE bottle 60 | HA298* | 29-Sep-2005 | |
| HIV | Nevirapine | Tablets 200mg | Mylan Laboratories Ltd | Mylan Laboratories Ltd, Nashik District, Maharashtra, India; Mission Vivacare Ltd, Pithampur, Dhar, M.P., India; Waluj, Aurangabad, Maharashtra; Inda | HDPE bottle 60; Blister 10 | HA396* | 25-Jul-2008 | |
| HIV | Nevirapine | Tablets 200mg | Macleods Pharmaceuticals Ltd | Kachigam, Daman, India | HDPE bottle 60; PVdC/PVC/Alu blister 6x10; 12x10 (USFDA) | HA465* | 29-Sep-2011 | |
| HIV | Nevirapine | Oral suspension 50mg/5ml | Cipla Ltd | Cipla Ltd, Goa, India; Meditab Specialties Pvt Ltd, Maharashtra, India; Indore, SEZ, Pithampur, Dist Dhar (M.P.), India | Amber coloured PET bottle 100ml, 240ml; Amber coloured glass bottle 25ml, 10ml | HA200 | 25-May-2009 | |
| HIV | Nevirapine | Oral suspension 10mg/ml | Boehringer Ingelheim | Roxane, Columbus, USA | HDPE bottle 240ml + syringe 5ml | HA188 | 28-Feb-2003 | |
| HIV | Ritonavir | Tablets 100mg | Mylan Laboratories Ltd | Sinnar, Nashik District, Maharashtra, India | HDPE bottle 30, 120 | HA467 | 14-Dec-2010 | |
| HIV | Ritonavir | Tablets 100mg | Abbott GmbH and Co. KG | Luwigshafen, Germany | HDPE bottle 30, 60 | HA491 | 01-Jun-2010 | |
| HIV | Ritonavir | Oral solution 80mg/ml | Abbott Laboratories | Queensborough, Kent, UK | PET bottle 90ml | HA096 | 20-Mar-2002 | |
| HIV | Ritonavir | Capsules 100mg | Abbott Laboratories | RP Scherer, Florida, USA; Beinheim, France | HDPE bottle 84 | HA095 | 20-Mar-2002 | |
| HIV | Saquinavir | Capsules 200mg | F.Hoffman-La Roche | RP Scherer, Baden, Germany | Glass bottle 180 | HA133 | 20-Mar-2002 | |
| HIV | Saquinavir | Capsules 200mg | F.Hoffman-La Roche | Basel, Switzerland | Glass bottle 270 | HA136 | 16-Dec-2002 | |
| HIV | Saquinavir | Tablets 500mg | F.Hoffman-La Roche | Madrid, Spain | HDPE bottle 120 | HA384 | 03-Nov-2006 | |
| HIV | Stavudine | Powder for oral solution 1mg/ml | Bristol-Myers Squibb | Evansville, Indiana, USA | HDPE bottle 200ml | HA333 | 23-May-2006 | |
| HIV | Stavudine | Powder for oral solution 1mg/ml | Cipla Ltd | Goa, India | HDPE bottle 200ml | HA367* | 25-Oct-2010 | |
| HIV | Stavudine | Capsules 40mg | Bristol-Myers Squibb | Emcure Pharmaceuticals USA, New Jersey (manufacturing and primary packaging), USA. Bristol-Myers Squibb, Anagni (Frosinone) (secondary packaging, testing and batch release), Italy. | Blister 14; HDPE bottle 60 | HA064 | 20-Mar-2002 | |
| HIV | Stavudine | Capsules 40mg | Ranbaxy Laboratories Ltd | Paonta Sahib, Himachal Pradesh, India | Blister 60; HDPE bottle 60 | HA297 | 23-May-2006 | |
| HIV | Stavudine | Capsules 40mg | Mylan Laboratories Ltd | Sinnar, Nashik District, Maharashtra, India | HDPE bottle 60; Blister 10 (USFDA) | HA395* | 07-Mar-2008 | |
| HIV | Stavudine | Capsules 30mg | Bristol-Myers Squibb | Emcure Pharmaceuticals USA, New Jersey (manufacturing and primary packaging), USA. Bristol-Myers Squibb, Anagni (Frosinone) (secondary packaging, testing and batch release), Italy. | Blister 14; HDPE bottle 60 | HA063 | 20-Mar-2002 | |
| HIV | Stavudine | Capsules 30mg | Aspen Pharmacare | Port Elizabeth, South Africa | Glass bottle 60 | HA251 | 29-Sep-2005 | |
| HIV | Stavudine | Capsules 30mg | Ranbaxy Laboratories Ltd | Paonta Sahib, Himachal Pradesh, India | Blister 60; HDPE bottle 60 | HA296 | 23-May-2006 | |
| HIV | Stavudine | Capsules 30mg | Strides Arcolab Ltd | Bangalore, India | HDPE bottle 60 | HA312* | 14-Aug-2006 | |
| HIV | Stavudine | Capsules 30mg | Mylan Laboratories Ltd | Sinnar, Nashik District, Maharashtra, India | HDPE bottle 60; Blister 10 (USFDA) | HA394* | 07-Mar-2008 | |
| HIV | Stavudine | Capsules 30mg | Macleods Pharmaceuticals Ltd | Kachigam, Daman, India | HDPE bottle 60 | HA460 | 08-Feb-2011 | |
| HIV | Stavudine | Capsules 20mg | Bristol-Myers Squibb | Emcure Pharmaceuticals USA, New Jersey (manufacturing and primary packaging), USA. Bristol-Myers Squibb, Anagni (Frosinone) (secondary packaging, testing and batch release), Italy. | Blister 14; HDPE bottle 60 | HA062 | 20-Mar-2002 | |
| HIV | Stavudine | Capsules 20mg | Aspen Pharmacare | Port Elizabeth, South Africa | Glass bottle 60 | HA252 | 29-Sep-2005 | |
| HIV | Stavudine | Capsules 15mg | Bristol-Myers Squibb | Emcure Pharmaceuticals USA, New Jersey (manufacturing and primary packaging), USA. Bristol-Myers Squibb, Anagni (Frosinone) (secondary packaging, testing and batch release), Italy. | Blister 14; HDPE bottle 60 | HA061 | 20-Mar-2002 | |
| HIV | Sulfadiazine | Tablets 500mg | Doms Recordati | Saint Victor, Parc Mecatronic, France | Blister 10 | HA034 | 20-Mar-2002 | |
| HIV | Sulfamethoxazole + Trimethoprim | Tablets 800mg + 160mg | F.Hoffman-La Roche | Basel, Switzerland | Blister,10 | HA131 | 29-May-2002 | |
| HIV | Sulfamethoxazole + Trimethoprim | Tablets 400mg + 80mg | F.Hoffman-La Roche | Basel, Switzerland | Blister,20,100 | HA132 | 16-Dec-2002 | |
| HIV | Sulfamethoxazole + Trimethoprim | Oral suspension (40mg + 8mg)/ml | F.Hoffman-La Roche | Basel, Switzerland | Bottle glass 100ml | HA130 | 28-Feb-2003 | |
| HIV | Tenofovir | Tablets 300mg | Gilead Sciences, Inc. | Patheon Inc., Mississauga,Ontario, Canada; Altana Pharma, Oranienburg GmbH, Oranienburg, Germany; Aspen Pharmacare, OSD Facility, Korsten, Port Elizabeth, South Africa |
HDPE bottle 30 | HA329 | 01-Mar-2006 | |
| HIV | Tenofovir disoproxil fumarate | Tablets 300mg | Cipla Ltd | Goa, India | HDPE bottle 30; HDPE bottle 1000 (USFDA) | HA401* | 30-Jun-2009 | |
| HIV | Tenofovir disoproxil fumarate | Tablets 300mg | Mylan Laboratories Ltd | Sinnar, Nashik District, Maharashtra, India; Waluj, Aurangabad, Maharashtra, India | HDPE bottle 30, 100; Blister 2 X 10 (USFDA) | HA410* | 27-Oct-2009 | |
| HIV | Tenofovir disoproxil fumarate | Tablets 300mg | Ranbaxy Laboratories Ltd | Paonta Sahib, Himachal Pradesh, India | HDPE bottle 30 | HA423 | 16-Dec-2009 | |
| HIV | Tenofovir disoproxil fumarate | Tablets 300mg | Hetero Labs Limited | Unit-III, Jeedimetla, Hyderabad, Andhra Pradesh, India | HDPE bottle 30; 30, 60, 100, 500, 1000 (USFDA) | HA508* | 31-Oct-2012 | |
| HIV | Vinblastine | Injection solution 1mg/ml | Cipla Ltd | Goa, India | Vials 10ml | HA050 | 20-Mar-2002 | |
| HIV | Zalcitabine | Tablets 0.75mg | F.Hoffman-La Roche | Basel, Switzerland; New Jersey, USA | Blister 6; Bottle Glass 100 | HA142 | 20-Mar-2002 | |
| HIV | Zalcitabine | Tablets 0.375mg | F.Hoffman-La Roche | Basel, Switzerland; New Jersey, USA | Blister 6; Bottle Glass 100 | HA141 | 20-Mar-2002 | |
| HIV | Zidovudine | Tablets 300mg | Cipla Ltd | Goa, India | Blister 5x10, 20x10, 40x10; Blister 10x10 (USFDA); HDPE bottle 60; HDPE bottle 1000 (USFDA) | HA051* | 11-Sep-2002 | |
| HIV | Zidovudine | Tablets 300mg | ViiV HealthCare | Glaxo Operations UK, Ltd, Ware, Hertfordshire, UK; Glaxo Wellcome SA, Aranda (packaging and release), Spain | Blister 28, 60; Bottle glass 28 | HA116 | 11-Sep-2002 | |
| HIV | Zidovudine | Tablets 300mg | Ranbaxy Laboratories Ltd | Paonta Sahib, Himachal Pradesh, India | Blister 10; HDPE bottle 60; Blister 8 (USFDA) | HA294* | 11-Aug-2005 | |
| HIV | Zidovudine | Tablets 300mg | Mylan Laboratories Ltd | Sinnar, Nashik District, Maharashtra, India | HDPE bottle 60; Blister 2 x 10 | HA404* | 25-Jul-2008 | |
| HIV | Zidovudine | Tablets 300mg | Hetero Labs Limited | Hyderabad, Andhra Pradesh, India | HDPE bottle 60, 600 | HA457* | 29-Sep-2010 | |
| HIV | Zidovudine | Tablets 300mg | Micro Labs Limited | Verna, Goa, India | PVDC/PVC/Alu blister 10; HDPE bottle 30, 60, 90 | HA483 | 20-Aug-2010 | |
| HIV | Zidovudine | Tablets 300mg | Macleods Pharmaceuticals Ltd | Kachigam, Daman, India | HDPE bottle 60; Alu/PVC/PVdC/Blister 10 x 10 | HA517 | 02-May-2012 | |
| HIV | Zidovudine | Tablets 100mg | Mylan Laboratories Ltd | Sinnar, Nashik District, Maharashtra, India | HDPE bottle 60 | HA464* | 30-Mar-2010 | |
| HIV | Zidovudine | Oral solution 50mg/5ml | Cipla Ltd | Cipla Ltd, Goa, India; Meditab Specialties Pvt Ltd, Maharashtra, India |
PET bottle 100ml; HDPE bottle 100ml, 240ml (USFDA) | HA054* | 20-Mar-2002 | |
| HIV | Zidovudine | Oral solution 50mg/5ml | ViiV HealthCare | Mississauga, Ontario, Canada | Glass bottle 200ml | HA115 | 20-Mar-2002 | |
| HIV | Zidovudine | Oral solution 50mg/5ml | Combino Pharm S.L. | Medea, Barcelona, Spain | PET bottle 200ml + syringe 10ml | HA184 | 01-Jan-2004 | |
| HIV | Zidovudine | Oral solution 50mg/5ml | Meditab Specialities Pvt Ltd | Maharashtra, India | PET bottle 100ml | HA431 | 15-Nov-2011 | |
| HIV | Zidovudine | Oral solution 50mg/5ml | Hetero Labs Limited | Unit-III, Jeedimetla, Hyderabad, Andhra Pradesh, India | HDPE bottle 240ml | HA486 | 03-Nov-2011 | |
| HIV | Zidovudine | Infusion solution 10mg/ml | ViiV HealthCare | Barnard Castle, County Durham, UK | Glass Vials 20ml | HA114 | 20-Mar-2002 | |
| HIV | Zidovudine | Dispersible tablets 60mg | Ranbaxy Laboratories Ltd | Paonta Sahib, Himachal Pradesh, India | HDPE bottle 60 | HA534 | 24-Jan-2013 | |
| HIV | Zidovudine | Capsules 300mg | Combino Pharm S.L. | Medea, Barcelona, Spain | Blister 60, 300 | HA029 | 16-Dec-2002 | |
| HIV | Zidovudine | Capsules 250mg | Combino Pharm S.L. | Medea, Barcelona, Spain | Blister 40, 300 | HA028 | 16-Dec-2002 | |
| HIV | Zidovudine | Capsules 250mg | ViiV HealthCare | S. C. Europharm, Brasov, Romania | Blister 40 | HA109 | 29-May-2002 | |
| HIV | Zidovudine | Capsules 100mg | Cipla Ltd | Goa, India; Indore, SEZ, Pithampur, District Dhar (M.P.), India | HDPE bottle 100; HDPE bottle 1000 (USFDA) | HA052* | 11-Sep-2002 | |
| HIV | Zidovudine | Capsules 100mg | ViiV HealthCare | S.C. Europharm, Brasov, Romania | Blister 100; Bottle glass 100 | HA108 | 29-May-2002 | |
| HIV | Zidovudine | Capsules 100mg | Combino Pharm S.L. | Medea, Barcelona, Spain | Al strip 100 | HA027 | 20-Mar-2002 | |
| IN | Oseltamivir (as phosphate) | Powder for oral suspension 12mg/ml | Roche Ltd | Grenzacherstr, Basel, Switzerland (Galenic bulk production); Rottendorf Pharma GmbH, Ennigerloh, Germany (Galenic bulk production); Wurmisweg, Kaiseraugst, Switzerland (packaging); GP Grenzach Produktions GmbH, Wyhlen, Germany (packaging) | Amber glass bottle 30g | IN003 | 21-Sep-2009 | |
| IN | Oseltamivir (as phosphate) | Capsules 75mg | Cipla Ltd | Goa, India | HDPE bottle 30; PVC/PE/PVdC Aluminum blister 10 | IN001 | 13-May-2009 | |
| IN | Oseltamivir (as phosphate) | Capsules 75mg | Strides Arcolab Limited | Anekal Taluk, Bangalore, India | PVDC/PVC/Alu blister | IN002 | 25-Oct-2010 | |
| IN | Oseltamivir (as phosphate) | Capsules 75mg | Roche Ltd | Grenzacherstr, Basel, Switzerland (Galenic bulk production); Catalent Germany Schorndorf GmbH, Schorndorf, Germany (Galenic bulk production); CENEXI SAS, Fontenay-sous-Bois, France (Galenic bulk production); Hoffmann-La Roche Inc., New Jersey, USA (Galenic bulk production); Patheon Inc., Cincinnati, OH, USA (Galenic bulk production); DSM Pharmaceuticals Inc, Greenville, USA (Galenic bulk production); Catalent Germany Schorndorf GmbH, Schorndorf, Germany (packaging); GP Grenzach Produktions GmbH, Grenzach-Wyhlen, Germany (packaging); Wurmisweg, Kaiseraugst, Switzerland (packaging) |
Blister (PVC/PE/PVDC, sealed with aluminium foil) 10 | IN006 | 21-Sep-2009 | |
| IN | Oseltamivir (as phosphate) | Capsules 45mg | Roche Ltd | Grenzacherstr, Basel, Switzerland (Galenic bulk production); Wurmisweg, Kaiseraugst, Switzerland (packaging) | Blister (PVC/PE/PVDC, sealed with aluminium foil) 10 | IN005 | 21-Sep-2009 | |
| IN | Oseltamivir (as phosphate) | Capsules 30mg | Roche Ltd | Grenzacherstr, Basel, Switzerland (Galenic bulk production); Wurmisweg, Kaiseraugst, Switzerland (packaging) |
Blister (PVC/PE/PVDC, sealed with aluminium foil) 10 | IN004 | 21-Sep-2009 | |
| IN | Zanamivir | Inhalation powder 5mg/dose | GlaxoSmithKline | GlaxoSmithKline Australia Pty Ltd, Boronia, Australia; Glaxo Wellcome Production, Evreux, France | Alu/Alu blister, 4 blisters per disk (a pack contains 1 or 5 Alu foil disks) | IN007 | 22-Sep-2009 | |
| MA | Amodiaquine | Film-coated tablets 150mg | Guilin Pharmaceutical Co. Ltd | Guilin, Guangxi, China | PVC/Alu blisters 6; Cardboard box 2 x 6 | MA045 | 30-Aug-2007 | |
| MA | Amodiaquine (as hydrochloride) + Artesunate | Tablets 67.5mg+25mg | Ipca Laboratories Ltd | Dadra and Nagar Haveli (U.T.), India | Alu/Alu blister 10x1x3, 25x3 | MA080 | 01-Jun-2012 | |
| MA | Amodiaquine (as hydrochloride) + Artesunate | Tablets 67.5mg + 25mg | Guilin Pharmaceutical Co., Ltd. | Guilin, Guangxi, China | Alu/PA/Alu/PVC blister 1 x 3 | MA083 | 16-Nov-2012 | |
| MA | Amodiaquine (as hydrochloride) + Artesunate | Tablets 270mg+100mg | Ipca Laboratories Ltd | Dadra and Nagar Haveli (U.T.), India | Alu/Alu blister 10x1x3, 10x1x6, 25x3, 25x6 | MA082 | 01-Jun-2012 | |
| MA | Amodiaquine (as hydrochloride) + Artesunate | Tablets 270mg + 100mg | Guilin Pharmaceutical Co., Ltd. | Guilin, Guangxi, China | Alu/PA/ALu/PVC blister 1 x 3, 1 x 6 | MA085 | 16-Nov-2012 | |
| MA | Amodiaquine (as hydrochloride) + Artesunate | Tablets 135mg+50mg | Ipca Laboratories Ltd | Dadra and Nagar Haveli (U.T.), India | Alu/Alu blister 10x1x3, 25x3 | MA081 | 01-Jun-2012 | |
| MA | Amodiaquine (as hydrochloride) + Artesunate | Tablets 135mg + 50mg | Guilin Pharmaceutical Co., Ltd. | Guilin, Guangxi, China | Alu/PA/Alu/PVC blister 1 x 3 | MA084 | 16-Nov-2012 | |
| MA | Amodiaquine (as hydrochloride) + Artesunate | Tablets (co-blistered) 153mg + 50mg | Strides Arcolab Limited | Bangalore, India | Alu/PVC/PE/PVDC blister 10 x (12+12), 10 x (6+6), 10 x (3+3) | MA074 | 22-Dec-2011 | |
| MA | Amodiaquine + Artesunate | Tablets 67.5mg + 25mg | Sanofi-Aventis Group | MAPHAR Laboratories, Casablanca, Morocco | Alu/Alu blister 3 x 1, 3 x 25 | MA056 | 14-Oct-2008 | |
| MA | Amodiaquine + Artesunate | Tablets 270mg + 100mg | Sanofi-Aventis Group | MAPHAR Laboratories, Casablanca, Morocco; Rottendorf Pharma, Ennigerloh, Germany; Batch released by: Sanofi-Aventis Maroc, Casablanca, Morocco | Alu/Alu blister 3 x 1, 3 x 25, 6 x 1, 6 x 25 | MA058 | 14-Oct-2008 | |
| MA | Amodiaquine + Artesunate | Tablets 153mg (200mg as hydrochloride) + Tablets 50mg | Ipca Laboratories Limited | Dadra and Nagar Haveli (U.T.), India | PVdC/PVC/Alu blister 12+12, 6+6, 3+3 | MA001 | 23-Apr-2008 | |
| MA | Amodiaquine + Artesunate | Tablets 153mg (200mg as hydrochloride) + Tablets 50mg | Cipla Ltd | Patalganga, India; Goa, India | PVC/PVDC/Alu blister 3 + 3, 6 + 6, 12 + 12 | MA047 | 11-Nov-2008 | |
| MA | Amodiaquine + Artesunate | Tablets 150mg + 50mg | Guilin Pharmaceutical Co. Ltd | Guilin, Guangxi, China | PVC/Alu blister 3x(4+4), 3+3, 6+6, 12+12 | MA046 | 30-Aug-2007 | |
| MA | Amodiaquine + Artesunate | Tablets 135mg + 50mg | Sanofi-Aventis Group | MAPHAR Laboratories, Casablanca, Morocco | Alu/Alu blister 3 x 1, 3 x 25 | MA057 | 14-Oct-2008 | |
| MA | Artemether + Lumefantrine | Tablets 20mg + 120mg | Ajanta Pharma Ltd | Paithan, Aurangabad, Maharashtra, India | PVC/PVdC/Alu blister 2 x 8; 3 x 8; 30 x 6; 30 x 12; 30 x 18; 30 x 24 | MA052 | 16-Dec-2008 | |
| MA | Artemether + Lumefantrine | Tablets 20mg + 120mg | Novartis Pharma | Beijing, China; Suffern, USA | Blister 6, 12, 18, 24 | MA026 | 26-Apr-2004 | |
| MA | Artemether + Lumefantrine | Tablets 20mg + 120mg | Ipca Laboratories Ltd | Dadra and Nagar Haveli (U.T.), India | PVDC/PVC/Alu blister 30 x 6, 30 x 12, 30 x 18, 30 x 24 | MA062 | 15-Dec-2009 | |
| MA | Artemether + Lumefantrine | Tablets 20mg + 120mg | Cipla Ltd | Patalganga, Himachal Pradesh, Goa, Kurkumbh, Indore, India; Quality Chemical Industries Ltd, Kampala, Uganda | PVC-PCTFE/Alu Blister 6,12,18,24; Alu/Alu Blister 6 (1x6), 12 (2x6), 18 (3x6), 24 (4x6) | MA064 | 22-May-2009 | |
| MA | Artemether + Lumefantrine | Dispersible tablets 20mg + 120mg | Novartis Pharma AG | Novartis Pharmaceuticals Corporation, Suffern, USA | PVC/PCTFE/PVC/Alu blister or PVC/PCTFE/Alu blister 30 X 6; 30 X 12; 30 X 18 | MA069 | 27-Feb-2009 | |
| MA | Artemether + Lumefantrine | Dispersible tablets 20mg + 120mg | Ajanta Pharma Ltd | Paithan, Aurangabad, Maharashtra, India | PVC/PVdC/Alu blister 1 x 6, 30 x 6, 1 x 12, 30 x 12 | MA092 | 19-Dec-2012 | |
| MA | Artemotil | Solution injection 50mg/ml | Artecef BV | Rotexmedica GmbH, Trittau, Germany | Glass ampoules 1ml | MA027 | 01-Mar-2006 | |
| MA | Artemotil | Solution injection 150mg/ml | Artecef BV | Rotexmedica GmbH, Trittau, Germany | Glass ampoules 1ml | MA028 | 01-Mar-2006 | |
| MA | Artesunate | Tablets 50mg | Ipca Laboratories Ltd | Dadra and Nagar Haveli (U.T.), India | PVdC/Al blisters 12 | MA038 | 30-Aug-2007 | |
| MA | Artesunate | Tablets 50mg | Guilin Pharmaceutical Co. Ltd | Guilin, Guangxi, China | Blister 12 | MA044 | 21-Dec-2005 | |
| MA | Artesunate | Powder for Injection 60mg | Guilin Pharmaceutical Co., Ltd. | Guilin, Guangxi, P.R. China | Vial [1 vial of artesunate powder is co-packed with 1 ampoule of sodium bicarbonate injection (1ml:50mg) and 1 ampoule of sodium chloride injection (5ml:45mg)] | MA051 | 05-Nov-2010 | |
| MA | Artesunate + [Sulfadoxine + Pyrimethamine] | Tablets + Tablets 50mg + [500mg + 25mg] | Guilin Pharmaceutical Co., Ltd. | Guilin, Guangxi, China | PVC/Alu blister 3 + 1; 6 + 2 | MA066 | 24-May-2012 | |
| MA | Artesunate + Mefloquine (as hydrochloride) | Tablets 25mg + 50mg | DNDi, Switzerland (Cipla Ltd is the supplier and is responsible for the product) | Cipla Ltd, Patalganga, India | Alu/Alu strip 1 x 3, 2 x 3 | MA078 | 12-Sep-2012 | |
| MA | Artesunate + Mefloquine (as hydrochloride) | Tablets 100mg + 200mg | DNDi, Switzerland (Cipla Ltd is the supplier and is responsible for the product) | Cipla Ltd, Patalganga, India | Alu/Alu strip 1 x 3, 2 x 3 | MA079 | 12-Sep-2012 | |
| RH | Ethinylestradiol + Desogestrel | Tablets 0.030mg + 0.150mg | NV Organon | Kloosterstraat, Oss, The Netherlands | PVC/Alu blister further packed in an Aluminium bag 21 + 7 (placebo) | RH025 | 29-Sep-2010 | |
| RH | Ethinylestradiol + Levonorgestrel | Tablets 30µg + 150µg | Famy Care Ltd | Valsad, Gujarat, India | PVC/PVdC/Alu blister 1x21, 3x21, 6x21, 13x21, 100x21 | RH013 | 29-Sep-2011 | |
| RH | Ethinylestradiol + Levonorgestrel | Tablets 30µg + 150µg | Cipla Ltd | Goa, India | Al/PVC/PVDC/PE strip 21 + 7 (placebo) per strip, (1 or 3 strips in a carton) | RH030 | 22-Dec-2011 | |
| RH | Ethinylestradiol + Levonorgestrel | Coated tablets 30µg + 150µg | Bayer Pharma AG | Bayer Weimar GmbH and Co. KG, Germany | PVC/Alu blister 3 x (21 + 7) (verum tablets + placebos) | RH003 | 26-May-2009 | |
| RH | Etonogestrel | Implants 68mg | NV Organon | Kloosterstraat, Oss, The Netherlands | Blister pack (polyethyleneterephtalate glycol sealed with coated paper) 1 implant (in the cannula of a disposable sterile applicator) | RH020 | 02-Jun-2010 | |
| RH | Levonorgestrel | Tablets 0.75mg | Gedeon Richter Plc | Budapest, Hungary | Al/PVC blister 1 x 2 | RH024 | 20-Aug-2010 | |
| RH | Levonorgestrel | Implants (without inserter) 2 rods each with 75mg | Bayer Oy | Turku, Finland | PE bag (manufactured from spunbonded PE film and a PET/PE film), 2 rods in one package | RH017 | 23-Sep-2009 | |
| RH | Levonorgestrel | Coated tablets 30µg | Bayer Pharma AG | Bayer Weimar GmbH and Co. KG, Germany | PVC/Alu blister 3 x 35 | RH002 | 26-May-2009 | |
| RH | Lynestrenol | Tablets 500µg | NV Organon | Kloosterstraat, Oss, The Netherlands | PVC/Alu strip 1 x 28, 3 x 28 | RH021 | 02-Jun-2010 | |
| RH | Medroxyprogesterone acetate | Suspension for injection 150mg/ml | Pfizer | Rijksweg, Puurs, Belgium | Glass vial 1ml | RH018 | 20-Aug-2010 | |
| RH | Norethisterone enantate | Injection 200mg/ml | Bayer Schering Pharma AG | Berlin, Germany | Glass ampoule 1ml (100 per carton) | RH022 | 05-Oct-2011 | |
| TB | Amikacin (as sulfate) | Injection 500mg/2ml | Cipla Ltd | Goa, India | Glass vial 2ml | TB217 | 14-Jan-2011 | |
| TB | Amikacin (as sulfate) | Injection 500mg/2ml | Pharmathen Hellas S.A. | Pharmathen S.A, Pallini Attiki, Greece; DEMO S.A. Krioneri Attiki, Greece | Glass ampoule 2ml (1, 5 or 10 ampoules per carton) | TB262 | 03-Apr-2013 | |
| TB | Cycloserine | Capsules 250mg | Aspen Pharmacare Limited | Port Elizabeth, South Africa | HDPE bottle 100 | TB166 | 19-Jun-2009 | |
| TB | Cycloserine | Capsules 250mg | Macleods Pharmaceuticals Ltd | Kachigam, Daman, India; Himachal Pradesh, India |
Al strip 10 | TB154 | 23-Mar-2007 | |
| TB | Cycloserine | Capsules 250mg | Dong-A Pharmaceutical Co Ltd | Cheonan, Chungcheongnam-do, Republic of Korea | Alu/Alu strip 10 x 10 | TB236 | 16-Nov-2012 | |
| TB | Ethambutol | Tablets 400mg | Cadila Pharmaceuticals Ltd | Dholka, Ahmedabad, India | HDPE bottle 1000; PVC/Alu blister 10x10; PVC/PVdC/Alu blister 24x28 | TB008 | 13-Nov-2003 | |
| TB | Ethambutol | Tablets 400mg | Macleods Pharmaceuticals Ltd | Kachigam, Daman, India | Blister 10, 28; HDPE bottle 1000 | TB134 | 23-Mar-2007 | |
| TB | Ethambutol + Isoniazid | Tablets 400mg + 150mg | Macleods Pharmaceuticals Ltd | Kachigam, Daman, India | Blister 10, 28; HDPE bottle 1000 | TB157 | 23-Mar-2007 | |
| TB | Ethambutol + Isoniazid + Pyrazinamide + Rifampicin | Tablets 275mg + 75mg + 400mg + 150mg | Wyeth Pakistan Ltd | Karachi, Pakistan | Blister 80 | TB024 | 13-Nov-2003 | Suspended |
| TB | Ethambutol + Isoniazid + Pyrazinamide + Rifampicin | Tablets 275mg + 75mg + 400mg + 150mg | Lupin Ltd | Aurangabad, India; Bari Brahmana, Jammu (J & K), India | Blister 4; HDPE bottle 100, 500, 1000 | TB070 | 13-Nov-2003 | |
| TB | Ethambutol + Isoniazid + Pyrazinamide + Rifampicin | Tablets 275mg + 75mg + 400mg + 150mg | Sandoz Pty Ltd | Strides Arcolab, Bangalore, India; Sandoz Pty Ltd, Kalwe, Navi Mumbai, Thane, India | PVC/PE/PVdC/Alu blister 30, 60, 120, 240, 672, 1000; Polypropylene containers 500, 1000; HDPE bottle 500 | TB090 | 14-Sep-2004 | |
| TB | Ethambutol + Isoniazid + Rifampicin | Tablets 275mg + 75mg + 150mg | Macleods Pharmaceuticals Ltd | Kachigam, Daman, India | Triple laminated LDPE/PET/AL bag further packed in HDPE container 1000; PVC/PVdC/Alu blister 10, 28 | TB183 | 22-Oct-2008 | |
| TB | Ethambutol hydrochloride | Tablets 400mg | Lupin Ltd | Chikalthana, Aurangabad, India; Bari Brahmana, Jammu (J & K), India | PVC/PVDC/Alu blister 10x10; LDPE bag in HDPE bottles 100, 500, 1000; | TB177 | 08-Apr-2010 | |
| TB | Ethambutol hydrochloride | Tablets 400mg | S.C. Antibiotice S.A. | Iasi, Romania | PVC/Alu blisters 2x10, 150x10 | TB264 | 28-Feb-2013 | |
| TB | Ethambutol hydrochloride + Isoniazid | Tablets 400mg + 150mg | Cadila Pharmaceuticals Ltd | Dholka, Ahmedabad, India | PVC/PVDC/Alu blister 10x10, 24x28, 14x28 | TB009 | 28-Apr-2010 | |
| TB | Ethambutol hydrochloride + Isoniazid | Tablets 400mg + 150mg | Lupin Ltd | Chikalthana, Aurangabad, India | Alu/PVC/PVDC blister 24 x 28; HDPE bottle 1000 | TB198 | 19-Dec-2012 | |
| TB | Ethambutol hydrochloride + Isoniazid + Pyrazinamide + Rifampicin | Tablets 275mg + 75mg + 400mg + 150mg | Svizera Europe B.V. - The Netherlands | Svizera Labs Private Ltd, Navi MUmbai, India | Alu/PVDC blister 24 x 28; HDPE bottle 1000 | TB193 | 19-Dec-2012 | |
| TB | Ethambutol hydrochloride + Isoniazid + Pyrazinamide + Rifampicin | Tablets 275mg + 75mg + 400mg + 150mg | Strides Arcolab Limited | Bangalore, India | Al/PVC/PE/PVDC blister 24 x 28, 18 x 10; HDPE bottle 1000 | TB216 | 24-May-2012 | |
| TB | Ethambutol Hydrochloride + Isoniazid + Pyrazinamide + Rifampicin | Film-coated tablets 275mg + 75mg + 400mg + 150mg | Macleods Pharmaceuticals Ltd | Kachigam, Daman, India | LDPE bag in sealed Alu sachet further packed in HDPE container 500, 1000; PVC/PVdC/Alu blister 10, 28 | TB168 | 07-Mar-2008 | |
| TB | Ethambutol hydrochloride + Isoniazid + Rifampicin | Tablets 275mg + 75mg + 150mg | Svizera Europe B.V. - The Netherlands | Svizera Labs Private Ltd, Navi Mumbai, India | PVC/Alu blister 24 x 28; HDPE bottle 1000 | TB192 | 19-Dec-2012 | |
| TB | Ethambutol hydrochloride + Isoniazid + Rifampicin | Tablets 275mg + 75mg + 150mg | Lupin Ltd | Chikalthana, Aurangabad, India | Alu/PVC/PVDC blister 24 x 28; HDPE bottle 1000 | TB199 | 11-Jan-2013 | |
| TB | Ethionamide | Tablets 250mg | Macleods Pharmaceuticals Ltd | Kachigam, Daman, India | AI/PET/LDPE triple lam pouch further in HDPE jar 100; Alu/Alu strip 10 | TB133 | 21-Dec-2007 | |
| TB | Ethionamide | Tablets 250mg | Cipla Ltd | Patalganga, India | Alu/PVC/PE/PVdC blister 10; HDPE bottle 100 | TB215 | 22-Dec-2011 | |
| TB | Ethionamide | Tablets 250mg | Micro Labs Limited | Hosur, Tamilnadu, India | PVDC/PVC/Alu blister 10; HDPE bottle 100 | TB242 | 19-Dec-2012 | |
| TB | Ethionamide | Tablets 250mg | Lupin Ltd | Chikalthana, Aurangabad, India | Alu/Alu strip 5 x 10; HDPE bottle 100 | TB207 | 19-Dec-2012 | |
| TB | Isoniazid | Tablets 300mg | Micro Labs Limited | Hosur, Tamilnadu, India | PE bag further packed in HDPE container 1000 | TB174 | 01-Nov-2010 | |
| TB | Isoniazid | Tablets 300mg | Macleods Pharmaceuticals Limited | Kachigam, Daman, India | LDPE bag further packed in HDPE container 1000; PVC/PVdC/Alu blister 10, 28 | TB179 | 23-Apr-2008 | |
| TB | Isoniazid | Tablets 300mg | S.C. Antibiotice S.A. | Iasi, Romania | PVC/Alu blisters 3x10, 150x10 | TB266 | 28-Feb-2013 | |
| TB | Isoniazid | Tablets 100mg | Micro Labs Limited | Hosur, Tamilnadu, India | PE bag further packed in HDPE container 1000 | TB173 | 01-Nov-2010 | |
| TB | Isoniazid | Tablets 100mg | Macleods Pharmaceuticals Limited | Kachigam, Daman, India | LDPE bag further packed in HDPE container 1000; PVC/PVdC/Alu blister 10, 28 | TB178 | 23-Apr-2008 | |
| TB | Isoniazid | Tablets 100mg | Lupin Ltd | Chikalthana, Aurangabad, India | Al/PVC/PVDC blister 100; HDPE bottle 100, 1000 | TB196 | 31-Oct-2012 | |
| TB | Isoniazid | Tablets 100mg | S.C. Antibiotice S.A. | Iasi, Romania | PVC/Alu blisters 2x10, 150x10 | TB265 | 28-Feb-2013 | |
| TB | Isoniazid + Pyrazinamide + Rifampicin | Dispersible tablets 30mg + 150mg + 60mg | Macleods Pharmaceuticals Ltd | Kachigam, Daman, India | Triple laminated LDPE/PET/AL bag further packed in HDPE container 1000; PVC/PVdC/Alu blister 10, 28; Alu/Alu strip 3 x 10, 10 x 10, 28 x 3, 14 x 6 | TB180 | 03-Mar-2009 | |
| TB | Isoniazid + Pyrazinamide + Rifampicin | Dispersible tablets 30mg + 150mg + 60mg | Lupin Ltd | Chikalthana, Aurangabad, India; Bari Brahmana, Jammu (J&K), India | Al/Al strip 15 x 6, 14 x 6 | TB185 | 02-Jul-2012 | |
| TB | Isoniazid + Rifampicin | Tablets 75mg + 150mg | Lupin Ltd | Aurangabad, India; Bari Brahmana, Jammu (J & K), India | Blister 15; HDPE bottle 100, 500, 1000 | TB068 | 19-Dec-2003 | |
| TB | Isoniazid + Rifampicin | Tablets 75mg + 150mg | Sandoz Pty Ltd | Strides Arcolab, Bangalore, India; Sandoz Pty Ltd, Kalwe, Navi Mumbai, Thane, India |
Alu/Alu blister 30, 60, 120, 240, 1000; PVC/PE/PVdC/Alu blister 10, 30, 60, 120, 240, 672, 1000; PP bottle 500, 1000; HDPE bottle 500 | TB085 | 14-Sep-2004 | |
| TB | Isoniazid + Rifampicin | Tablets 75mg + 150mg | Svizera Europe B.V. - The Netherlands | Svizera Labs Private Ltd, Navi Mumbai, India | PVC/Alu blister 24 x 28; HDPE jar 1000 | TB189 | 19-Dec-2012 | |
| TB | Isoniazid + Rifampicin | Tablets 75mg + 150mg | Strides Arcolab Limited | Bangalore, India | Al/PVC/PE/PVDC blister 24 x 28, 48 x 10; HDPE bottle 1000 | TB202 | 24-May-2012 | |
| TB | Isoniazid + Rifampicin | Tablets 150mg + 150mg | Lupin Ltd | Chikalthana, Aurangabad, India | PVC/PVDC/Alu blister 24 x 28; HDPE bottle 1000 | TB195 | 29-Jan-2013 | |
| TB | Isoniazid + Rifampicin | Film-coated tablets 75mg + 150mg | Macleods Pharmaceutical Ltd | Kachigam, Daman, India | PET/Alu/LLDPE triple laminated sachet further in HDPE container 500, 1000; PVC/PVdC/Alu blister 10, 28 | TB158 | 07-Mar-2008 | |
| TB | Isoniazid + Rifampicin | Dispersible tablets 60mg + 60mg | Macleods Pharmaceuticals Ltd | Kachigam, Daman, India | Triple laminated LDPE/PET/AL bag further packed in HDPE container 1000; PVC/PVdC/Alu blister 3 x 28, 24 x 28, 10 x 10; Alu/Alu strip 3 x 10, 10 x 10, 28 x 3, 14 x 6 | TB182 | 09-Nov-2009 | |
| TB | Isoniazid + Rifampicin | Dispersible tablets 30mg + 60mg | Macleods Pharmaceuticals Ltd | Kachigam, Daman, India | Triple laminated LDPE/PET/AL bag further packed in HDPE container 1000; PVC/PVdC/Alu blister 10, 28; Alu/Alu strip 3 x 10, 10 x 10, 28 x 3, 14 x 6 | TB181 | 03-Mar-2009 | |
| TB | Isoniazid + Rifampicin | Dispersible tablets 30mg + 60mg | Lupin Ltd | Chikalthana, Aurangabad, India; Bari Brahmana, Jammu (J&K), India | Al/Al strip 15 x 6, 14 x 6 | TB184 | 02-Jul-2012 | |
| TB | Isoniazid + Rifampicin | Capsules 150mg + 300mg | S.C. Antibiotice S.A. | Iasi, Romania | PVC/Alu blisters 1x10, 100x10 | TB270 | 28-Feb-2013 | |
| TB | Levofloxacin | Tablets 500mg | Cipla Ltd | Goa, India | Alu/PVC blister 10; HDPE bottle 50 | TB227 | 22-Dec-2011 | |
| TB | Levofloxacin | Tablets 500mg | Micro Labs Limited | Hosur, Tamilnadu, India | PVC/Alu blister 10 x 10 | TB238 | 03-Oct-2012 | |
| TB | Levofloxacin | Tablets 250mg | Cipla Ltd | Goa, India | Alu/PVC blister 10; HDPE bottle 50 | TB205 | 22-Dec-2011 | |
| TB | Levofloxacin | Tablets 250mg | Micro Labs Limited | Hosur, Tamilnadu, India | PVC/Alu blister 10 x 10 | TB237 | 03-Oct-2012 | |
| TB | Moxifloxacin (as hydrochloride) | Tablets 400mg | Cipla Ltd | Patalganga, India | HDPE bottle 30, 100, 1000; Blister 5 | TB210 | 01-Nov-2010 | |
| TB | Moxifloxacin (as hydrochloride) | Tablets 400mg | Macleods Pharmaceuticals Ltd | Kachigam, Daman, India | Alu/Alu cold form blister 1 x 5; Alu/Alu strip 1 x 5 | TB230 | 16-Nov-2012 | |
| TB | Ofloxacin | Tablets 400mg | Micro Labs Limited | Hosur, Tamilnadu, India | PVC/Alu blister 10 x 10; HDPE bottle 100 | TB241 | 11-Sep-2012 | |
| TB | Ofloxacin | Tablets 400mg | Cipla Ltd | Patalganga, India | Alu/PVC blister 10 x 10; HDPE bottle 100, 500, 1000 | TB225 | 22-Dec-2011 | |
| TB | Ofloxacin | Tablets 200mg | Macleods Pharmaceuticals Ltd | Solan, Himachal Pradesh, India | Al/PVC blister 10; HDPE bottle 100 | TB218 | 31-Oct-2012 | |
| TB | Ofloxacin | Tablets 200mg | Cipla Ltd | Patalganga, India | Alu/PVC blister 10 x 10; HDPE bottle 100, 500, 1000 | TB224 | 22-Dec-2011 | |
| TB | Ofloxacin | Tablets 200mg | Micro Labs Limited | Hosur, Tamilnadu, India | PVC/Alu blister 10 x 10; HDPE bottle 100 | TB240 | 11-Sep-2012 | |
| TB | p-Aminosalicylic acid (as sodium salt) (common name) | Powder for oral solution 4 g | OlainFarm JSC | Olaine, Latvia | 25 or 300 per box | TB229 | 22-Mar-2011 | |
| TB | Para-aminosalicylate sodium | Delayed release granules 60% w/w | Macleods Pharmaceuticals Ltd | Kachigam, Daman, India; Solan, Himachal Pradesh, India | LDPE bag placed in triple laminated Alu/PET/Alu/LLDPE sachet further packed in HDPE container 100g; PET/Alu/LLDPE Sachet 9.2g | TB156 | 14-Dec-2009 | |
| TB | Prothionamide | Tablets 250mg | Micro Labs Limited | Hosur, Tamilnadu, India | PVC/PVdC-Alu blisters 10 x 14; HDPE bottle 100 | TB239 | 25-Feb-2013 | |
| TB | Pyrazinamide | Tablets 500mg | Micro Labs Limited | Hosur, Tamilnadu, India | PE bag further packed in HDPE container 1000 | TB172 | 29-Jun-2009 | |
| TB | Pyrazinamide | Tablets 500mg | Macleods Pharmaceuticals Ltd | Kachigam, Daman, India | Alu/PVC blister 3 x 10, 10 x 10, 3 x 28, 24 x 28; HDPE bottle 1000 | TB243 | 04-Dec-2012 | |
| TB | Pyrazinamide | Tablets 500mg | S.C. Antibiotice S.A. | Iasi, Romania | PVC/Alu blisters 2x10, 150x10 | TB267 | 28-Feb-2013 | |
| TB | Pyrazinamide | Tablets 400mg | Cadila Pharmaceuticals Ltd | Dholka, Ahmedabad, India | HDPE bottle 1000; PVC/Alu blister 10x10; PVC/PVdC/Alu blister 24x28 | TB015 | 13-Nov-2003 | |
| TB | Pyrazinamide | Tablets 400mg | Macleods Pharmaceuticals Ltd | Kachigam, Daman, India | HDPE bottle 1000 ; PVC/Alu blister 10; 28 | TB159 | 23-Mar-2007 | |
| TB | Pyrazinamide | Tablets 400mg | Micro Labs Limited | Hosur, Tamilnadu, India | PE bag further packed in HDPE container 1000 | TB171 | 29-Jun-2009 | |
| TB | Rifampicin | Capsules 300mg | S.C. Antibiotice S.A. | Iasi, Romania | PVC/Alu blisters 1x10, 100x10 | TB269 | 28-Feb-2013 | |
| TB | Rifampicin | Capsules 150mg | S.C. Antibiotice S.A. | Iasi, Romania | PVC/Alu blisters 2x10, 100x10 | TB268 | 28-Feb-2013 |