FDA — authorised 18 June 2012
- Application: ANDA091294
- Marketing authorisation holder: MYLAN PHARMS INC
- Local brand name: ABACAVIR SULFATE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 ABACAVIR SULFATE in United States
FDA authorised ABACAVIR SULFATE on 18 June 2012 · 4,027 US adverse-event reports
Marketing authorisations
FDA — authorised 17 December 2012
- Application: ANDA201570
- Marketing authorisation holder: APOTEX INC
- Local brand name: ABACAVIR SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 December 2012
- Application: ANDA077844
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: ABACAVIR SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 September 2013
- Application: ANDA091560
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: ABACAVIR SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 December 2015
- Application: ANDA205412
- Marketing authorisation holder: HETERO LABS LTD V
- Local brand name: ABACAVIR SULFATE AND LAMIVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 September 2016
- Application: ANDA201107
- Marketing authorisation holder: HETERO LABS LTD III
- Local brand name: ABACAVIR SULFATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 29 September 2016
- Application: ANDA079246
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: ABACAVIR SULFATE AND LAMIVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 March 2017
- Application: ANDA206151
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: ABACAVIR SULFATE AND LAMIVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 March 2017
- Application: ANDA091144
- Marketing authorisation holder: CIPLA
- Local brand name: ABACAVIR SULFATE AND LAMIVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 November 2017
- Application: ANDA078119
- Marketing authorisation holder: CIPLA
- Local brand name: ABACAVIR SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 March 2018
- Application: ANDA077950
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: ABACAVIR SULFATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 15 November 2018
- Application: ANDA208990
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: ABACAVIR SULFATE AND LAMIVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 November 2018
- Application: ANDA090159
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: ABACAVIR SULFATE AND LAMIVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 March 2022
- Application: NDA215413
- Marketing authorisation holder: VIIV HLTHCARE
- Local brand name: TRIUMEQ PD
- Indication: TABLET, FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 25 July 2022
- Application: ANDA216332
- Marketing authorisation holder: LAURUS
- Local brand name: ABACAVIR SULFATE AND LAMIVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA078348
- Marketing authorisation holder: CIPLA LIMITED
- Local brand name: ABACAVIR SULFATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA
- Application: ANDA090519
- Marketing authorisation holder: MATRIX LABS LTD
- Local brand name: ABACAVIR SULFATE; LAMIVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA202381
- Marketing authorisation holder: MYLAN LABS
- Local brand name: ABACAVIR SULFATE; LAMIVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA022547
- Marketing authorisation holder: CIPLA LIMITED
- Local brand name: ABACAVIR SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA200733
- Marketing authorisation holder: MATRIX LABS LTD
- Local brand name: ABACAVIR SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA022293
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: ABACAVIR SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA022295
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: ABACAVIR SULFATE; LAMIVUDINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA202007
- Marketing authorisation holder: CIPLA LIMITED
- Local brand name: ABACAVIR SULFATE; LAMIVUDINE
- Indication: TABLET, FOR SUSPENSION — ORAL
- Status: approved
FDA
- Application: ANDA078742
- Marketing authorisation holder: MATRIX LABS
- Local brand name: ABACAVIR SULFATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- 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: 20 April 2025 – 20 April 2026
- Total reports: 4,027
Most-reported reactions
- Exposure During Pregnancy — 526 reports (13.06%)
- Off Label Use — 433 reports (10.75%)
- Hepatic Enzyme Increased — 426 reports (10.58%)
- Pyrexia — 423 reports (10.5%)
- Headache — 414 reports (10.28%)
- Hypertension — 399 reports (9.91%)
- Hypersensitivity — 362 reports (8.99%)
- Hyperhidrosis — 361 reports (8.96%)
- Pain — 352 reports (8.74%)
- Joint Swelling — 331 reports (8.22%)
ABACAVIR SULFATE 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 ABACAVIR SULFATE approved in United States?
Yes. FDA authorised it on 18 June 2012; FDA authorised it on 17 December 2012; FDA authorised it on 17 December 2012.
Who is the marketing authorisation holder for ABACAVIR SULFATE in United States?
MYLAN PHARMS INC holds the US marketing authorisation.