🇺🇸 Abacavir sulfate, Lamivudine and Zidovudine in United States

FDA authorised Abacavir sulfate, Lamivudine and Zidovudine on 5 December 2013 · 22 US adverse-event reports

Marketing authorisations

FDA — authorised 5 December 2013

  • Application: ANDA202912
  • Marketing authorisation holder: LUPIN
  • Local brand name: ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Application: ANDA090309
  • Marketing authorisation holder: MYLAN PHARMA
  • Local brand name: ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

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.

Most-reported reactions

  1. Drug Exposure During Pregnancy — 3 reports (13.64%)
  2. Pyrexia — 3 reports (13.64%)
  3. Congenital Anomaly — 2 reports (9.09%)
  4. Diarrhoea — 2 reports (9.09%)
  5. Hemivertebra — 2 reports (9.09%)
  6. Malaise — 2 reports (9.09%)
  7. Myocardial Infarction — 2 reports (9.09%)
  8. Oesophageal Atresia — 2 reports (9.09%)
  9. Pruritus — 2 reports (9.09%)
  10. Rash — 2 reports (9.09%)

Source database →

Other Infectious Disease / Virology approved in United States

Frequently asked questions

Is Abacavir sulfate, Lamivudine and Zidovudine approved in United States?

Yes. FDA authorised it on 5 December 2013; FDA has authorised it.

Who is the marketing authorisation holder for Abacavir sulfate, Lamivudine and Zidovudine in United States?

LUPIN holds the US marketing authorisation.