🇺🇸 TETRACYCLINE in United States

FDA authorised TETRACYCLINE on 8 October 1957 · 4,547 US adverse-event reports

Marketing authorisations

FDA — authorised 8 October 1957

  • Application: NDA050278
  • Marketing authorisation holder: AVET
  • Status: supplemented

FDA — authorised 10 February 1971

  • Application: ANDA061147
  • Marketing authorisation holder: STRIDES PHARMA INTL
  • Status: approved

FDA — authorised 18 September 2018

  • Application: ANDA210674
  • Marketing authorisation holder: AMNEAL PHARMS NY
  • Status: approved

FDA — authorised 7 November 2018

  • Application: ANDA210662
  • Marketing authorisation holder: BRECKENRIDGE
  • Status: approved

FDA — authorised 6 March 2023

  • Application: ANDA205770
  • Marketing authorisation holder: PH HEALTH
  • Status: supplemented

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 — 1,818 reports (39.98%)
  2. Off Label Use — 358 reports (7.87%)
  3. Nausea — 353 reports (7.76%)
  4. Drug Ineffective — 344 reports (7.57%)
  5. Rash — 334 reports (7.35%)
  6. Pain — 296 reports (6.51%)
  7. Vomiting — 290 reports (6.38%)
  8. Headache — 257 reports (5.65%)
  9. Fatigue — 254 reports (5.59%)
  10. Urticaria — 243 reports (5.34%)

Source database →

TETRACYCLINE 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 TETRACYCLINE approved in United States?

Yes. FDA authorised it on 8 October 1957; FDA authorised it on 10 February 1971; FDA authorised it on 18 September 2018.

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

AVET holds the US marketing authorisation.