FDA — authorised 8 December 1998
- Application: NDA021003
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: EPIVIR-HBV
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Antiretroviral therapy alone in United States
FDA authorised Antiretroviral therapy alone on 8 December 1998
Marketing authorisations
FDA — authorised 8 December 1998
- Application: NDA021004
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: EPIVIR-HBV
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 31 December 2002
- Application: NDA021453
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Local brand name: ZERIT XR
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 29 December 2008
- Application: ANDA078957
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: STAVUDINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 December 2008
- Application: ANDA079069
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: STAVUDINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 December 2008
- Application: ANDA077774
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: STAVUDINE
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA — authorised 29 December 2008
- Application: ANDA077672
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: STAVUDINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 20 March 2009
- Application: ANDA078030
- Marketing authorisation holder: CIPLA LTD
- Local brand name: STAVUDINE
- Indication: FOR SOLUTION — ORAL
- Status: approved
FDA — authorised 17 November 2011
- Application: ANDA202032
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: LAMIVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 December 2011
- Application: ANDA091606
- Marketing authorisation holder: APOTEX
- Local brand name: LAMIVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 May 2012
- Application: ANDA090246
- Marketing authorisation holder: LUPIN LTD
- Local brand name: LAMIVUDINE AND ZIDOVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 January 2014
- Application: ANDA202941
- Marketing authorisation holder: APOTEX
- Local brand name: LAMIVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 January 2014
- Application: ANDA203260
- Marketing authorisation holder: HETERO LABS LTD V
- Local brand name: LAMIVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 January 2014
- Application: ANDA203277
- Marketing authorisation holder: HETERO LABS LTD V
- Local brand name: LAMIVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 February 2014
- Application: ANDA203259
- Marketing authorisation holder: HETERO LABS LTD V
- Local brand name: LAMIVUDINE AND ZIDOVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 August 2014
- Application: ANDA204005
- Marketing authorisation holder: NATCO
- Local brand name: LAMIVUDINE AND ZIDOVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 October 2014
- Application: ANDA203564
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: LAMIVUDINE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 18 December 2014
- Application: ANDA205217
- Marketing authorisation holder: LUPIN
- Local brand name: LAMIVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 December 2014
- Application: ANDA204002
- Marketing authorisation holder: AUROBINDO PHARMA USA
- Local brand name: LAMIVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 February 2015
- Application: NDA206510
- Marketing authorisation holder: MERCK SHARP DOHME
- Local brand name: DUTREBIS
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 May 2015
- Application: ANDA079128
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: LAMIVUDINE AND ZIDOVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 September 2015
- Application: ANDA079124
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: LAMIVUDINE AND ZIDOVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 March 2016
- Application: ANDA204528
- Marketing authorisation holder: NATCO
- Local brand name: LAMIVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 November 2016
- Application: ANDA077695
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: LAMIVUDINE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 21 November 2016
- Application: ANDA206974
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Local brand name: LAMIVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 November 2016
- Application: ANDA203586
- Marketing authorisation holder: BRECKENRIDGE
- Local brand name: LAMIVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 November 2016
- Application: ANDA077464
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: LAMIVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 March 2017
- Application: ANDA077221
- Marketing authorisation holder: CIPLA
- Local brand name: LAMIVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 May 2017
- Application: ANDA077558
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: LAMIVUDINE AND ZIDOVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 February 2018
- Application: NDA022141
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: CIMDUO
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 April 2018
- Application: ANDA206375
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: LAMIVUDINE AND ZIDOVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 April 2018
- Application: ANDA090457
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: LAMIVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 May 2018
- Application: NDA022344
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 August 2018
- Application: NDA205626
- Marketing authorisation holder: MICRO LABS
- Local brand name: LAMIVUDINE, NEVIRAPINE AND ZIDOVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 August 2018
- Application: ANDA090679
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: LAMIVUDINE AND ZIDOVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 September 2018
- Application: ANDA077411
- Marketing authorisation holder: CIPLA
- Local brand name: LAMIVUDINE AND ZIDOVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 March 2019
- Application: ANDA078545
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: LAMIVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 May 2019
- Application: ANDA090198
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: LAMIVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 October 2023
- Application: ANDA091475
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: LAMIVUDINE
- Indication: SOLUTION — ORAL
- Status: approved
FDA
- Application: NDA202171
- Marketing authorisation holder: MATRIX LABS LTD
- Local brand name: LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE; NEVIRAPINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA202529
- Marketing authorisation holder: RANBAXY LABS LTD
- Local brand name: LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA022459
- Marketing authorisation holder: HETERO DRUGS LTD
- Local brand name: LAMIVUDINE/TENOFOVIR DISOPROXIL FUMARATE FDC TABS
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA078587
- Marketing authorisation holder: EMCURE PHARMA
- Local brand name: STAVUDINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA078256
- Marketing authorisation holder: STRIDES ACROLAB
- Local brand name: STAVUDINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA077357
- Marketing authorisation holder: RANBAXY
- Local brand name: LAMIVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA022177
- Marketing authorisation holder: STRIDES ACROLAB
- Local brand name: STAVUDINE; LAMIVUDINE; NEVIRAPINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA200793
- Marketing authorisation holder: MATRIX LABS
- Local brand name: LAMIVUDINE/NEVIRAPINE/ZIDOVUDINE TABLETS
- Indication: TABLET, FOR SUSPENSION — ORAL
- Status: approved
FDA
- Application: NDA203283
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA203076
- Marketing authorisation holder: CIPLA LTD
- Local brand name: LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE
- Indication: TABLET — ORAL SUSPENSION
- Status: approved
FDA
- Application: NDA021837
- Marketing authorisation holder: STRIDES ARCOLAB
- Local brand name: STAVUDINE; LAMIVUDINE; NEVIRAPINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA021838
- Marketing authorisation holder: STRIDES ACROLAB
- Local brand name: STAVUDINE; LAMIVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA022356
- Marketing authorisation holder: HETERO DRUGS LTD
- Local brand name: LAMIVUDINE, ZIDOVUDINE TABS 150MG/300MG CO-PACKAGED WITH NEVIRAPINE TABS 200MG
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA021988
- Marketing authorisation holder: STRIDES ACROLAB
- Local brand name: Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA078636
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: LAMIVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA202589
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA022347
- Marketing authorisation holder: PHARMACARE LTD
- Local brand name: STAVUDINE; LAMIVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA021854
- Marketing authorisation holder: STRIDES ACROLAB
- Local brand name: STAVUDINE; LAMIVUDINE W/NEVIRAPINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA021969
- Marketing authorisation holder: CIPLA LIMITED
- Local brand name: LAMIVUDINE; STAVUDINE; NEVIRAPINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA206040
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: LAMIVUDINE; ZIDOVUDINE; EFAVIRENZ
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA204505
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE; NEVIRAPINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA022346
- Marketing authorisation holder: PHARMACARE LTD
- Local brand name: STAVUDINE; LAMIVUDINE; NEVIRAPINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA022342
- Marketing authorisation holder: EMCURE PHARMA
- Local brand name: STAVUDINE; LAMIVUDINE; NEVIRAPINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA021974
- Marketing authorisation holder: CIPLA LIMITED
- Local brand name: LAMIVUDINE; STAVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA022085
- Marketing authorisation holder: MATRIX LABS
- Local brand name: LAMIVUDINE; STAVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA202685
- Marketing authorisation holder: STRIDES ARCOLAB LTD
- Local brand name: LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE
- Indication: TABLET, FOR SUSPENSION — ORAL
- Status: approved
FDA
- Application: NDA205355
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE; NEVIRAPINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA200406
- Marketing authorisation holder: MICRO LABS LTD
- Local brand name: LAMIVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA022479
- Marketing authorisation holder: HETERO DRUGS LTD
- Local brand name: LAMIVUDINE AND STAVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA021944
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: LAMIVUDINE; ZIDOVUDINE; ABACAVIR
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA022097
- Marketing authorisation holder: STRIDES ACROLAB
- Local brand name: STAVUDINE; LAMIVUDINE; EFAVIRENZ
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA207315
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: NDA022096
- Marketing authorisation holder: STRIDES ACROLAB
- Local brand name: LAMIVUDINE; ZIDOVUDINE; EFAVIRENZ
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA078850
- Marketing authorisation holder: INVAGEN PHARMS
- Local brand name: LAMIVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA022464
- Marketing authorisation holder: STRIDES ARCOLAB LTD
- Local brand name: LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA202157
- Marketing authorisation holder: HETERO LABS UNIT III
- Local brand name: LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA022061
- Marketing authorisation holder: MATRIX LABS
- Local brand name: LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA077980
- Marketing authorisation holder: CIPLA LIMITED
- Local brand name: LAMIVUDINE
- Indication: SOLUTION — ORAL
- Status: approved
FDA
- Application: ANDA090433
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: LAMIVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA022541
- Marketing authorisation holder: MACLEODS PHARMA
- Local brand name: LAMIVUDINE AND STAVUDINE
- Indication: TABLET — ORAL
- Status: approved
Antiretroviral therapy alone in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Antiretroviral therapy alone approved in United States?
Yes. FDA authorised it on 8 December 1998; FDA authorised it on 8 December 1998; FDA authorised it on 31 December 2002.
Who is the marketing authorisation holder for Antiretroviral therapy alone in United States?
GLAXOSMITHKLINE holds the US marketing authorisation.