FDA — authorised 5 December 2013
- Application: ANDA202912
- Marketing authorisation holder: LUPIN LTD
- Status: approved
🇺🇸 Abacavir/Lamivudine in United States
FDA authorised Abacavir/Lamivudine on 5 December 2013 · 766 US adverse-event reports
Marketing authorisations
FDA — authorised 15 December 2017
- Application: ANDA078064
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: EFAVIRENZ
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 5 February 2018
- Application: NDA208255
- Marketing authorisation holder: MYLAN
- Local brand name: SYMFI LO
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 March 2018
- Application: NDA022142
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: SYMFI
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 April 2018
- Application: ANDA078886
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: EFAVIRENZ
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 June 2018
- Application: ANDA204766
- Marketing authorisation holder: CIPLA
- Local brand name: EFAVIRENZ
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 September 2018
- Application: ANDA077673
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: EFAVIRENZ
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 November 2018
- Application: ANDA091215
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 March 2019
- Application: NDA210649
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 May 2020
- Application: ANDA212786
- Marketing authorisation holder: LAURUS
- Local brand name: EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 June 2021
- Application: ANDA078509
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: EFAVIRENZ
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 December 2021
- Application: ANDA213541
- Marketing authorisation holder: LAURUS
- Local brand name: EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 October 2023
- Application: ANDA201802
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: EFAVIRENZ; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 May 2024
- Application: ANDA091579
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: EFAVIRENZ
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA202990
- Marketing authorisation holder: PAR FORMULATIONS PRIVATE LTD
- Local brand name: EFAVIRENZ
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA077916
- Marketing authorisation holder: CIPLA LIMITED
- Local brand name: EFAVIRENZ
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA022461
- Marketing authorisation holder: MATRIX LABS LTD
- Local brand name: EFAVIRENZ
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA090155
- Marketing authorisation holder: CIPLA LIMITED
- Local brand name: EFAVIRENZ
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA207895
- Marketing authorisation holder: PHARMACARE LTD
- Local brand name: EFAVIRENZ
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA091175
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: EFAVIRENZ
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA204004
- Marketing authorisation holder: MYLAN PHARMS INC
- Local brand name: EPZICOM
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA078958
- Marketing authorisation holder: EMCURE PHARMA
- Local brand name: EFAVIRENZ
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA204119
- Marketing authorisation holder: HETERO DRUGS LTD
- Local brand name: EFAVIRENZ, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA078883
- Marketing authorisation holder: MATRIX LABS
- Local brand name: EFAVIRENZ
- Indication: TABLET — ORAL
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 21 April 2025 – 21 April 2026
- Total reports: 766
Most-reported reactions
- Exposure During Pregnancy — 105 reports (13.71%)
- Foetal Exposure During Pregnancy — 92 reports (12.01%)
- Pyrexia — 88 reports (11.49%)
- Rash — 83 reports (10.84%)
- Pain — 69 reports (9.01%)
- Upper Respiratory Tract Infection — 68 reports (8.88%)
- Virologic Failure — 67 reports (8.75%)
- Off Label Use — 66 reports (8.62%)
- Thrombocytopenia — 65 reports (8.49%)
- Asthma — 63 reports (8.22%)
Other Infectious Disease / Virology approved in United States
Frequently asked questions
Is Abacavir/Lamivudine approved in United States?
Yes. FDA authorised it on 5 December 2013; FDA authorised it on 15 December 2017; FDA authorised it on 5 February 2018.
Who is the marketing authorisation holder for Abacavir/Lamivudine in United States?
LUPIN LTD holds the US marketing authorisation.