🇺🇸 penicillin in United States

FDA authorised penicillin on 3 July 1968 · 13,860 US adverse-event reports

Marketing authorisations

FDA — authorised 3 July 1968

  • Application: ANDA060711
  • Marketing authorisation holder: TEVA
  • Status: supplemented

FDA — authorised 31 July 1968

  • Application: ANDA060456
  • Marketing authorisation holder: TEVA
  • Status: supplemented

FDA — authorised 25 June 1990

  • Application: NDA050638
  • Marketing authorisation holder: BAXTER HLTHCARE
  • Status: supplemented

FDA — authorised 26 February 2001

  • Application: ANDA065068
  • Marketing authorisation holder: SANDOZ
  • Status: supplemented

FDA — authorised 30 August 2002

  • Application: ANDA065079
  • Marketing authorisation holder: SANDOZ
  • 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.

Most-reported reactions

  1. Drug Hypersensitivity — 3,708 reports (26.75%)
  2. Rash — 1,305 reports (9.42%)
  3. Dyspnoea — 1,225 reports (8.84%)
  4. Fatigue — 1,182 reports (8.53%)
  5. Pain — 1,112 reports (8.02%)
  6. Drug Ineffective — 1,108 reports (7.99%)
  7. Hypersensitivity — 1,108 reports (7.99%)
  8. Nausea — 1,059 reports (7.64%)
  9. Chronic Kidney Disease — 1,042 reports (7.52%)
  10. Diarrhoea — 1,011 reports (7.29%)

Source database →

Other Immunology approved in United States

Frequently asked questions

Is penicillin approved in United States?

Yes. FDA authorised it on 3 July 1968; FDA authorised it on 31 July 1968; FDA authorised it on 25 June 1990.

Who is the marketing authorisation holder for penicillin in United States?

TEVA holds the US marketing authorisation.