🇺🇸 TRIFLUPROMAZINE HYDROCHLORIDE in United States

FDA authorised TRIFLUPROMAZINE HYDROCHLORIDE on 16 September 1957 · 12 US adverse-event reports

Marketing authorisations

FDA — authorised 16 September 1957

  • Application: NDA011123
  • Marketing authorisation holder: BRISTOL MYERS SQUIBB
  • Local brand name: VESPRIN
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 6 January 1958

  • Application: NDA011325
  • Marketing authorisation holder: APOTHECON
  • Local brand name: VESPRIN
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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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. Pyrexia — 2 reports (16.67%)
  2. Stevens-Johnson Syndrome — 2 reports (16.67%)
  3. Adverse Event — 1 report (8.33%)
  4. Agranulocytosis — 1 report (8.33%)
  5. Alopecia — 1 report (8.33%)
  6. Anaemia — 1 report (8.33%)
  7. Asthenia — 1 report (8.33%)
  8. Blister — 1 report (8.33%)
  9. Cardiac Failure — 1 report (8.33%)
  10. Cardiovascular Disorder — 1 report (8.33%)

Source database →

TRIFLUPROMAZINE HYDROCHLORIDE 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 TRIFLUPROMAZINE HYDROCHLORIDE approved in United States?

Yes. FDA authorised it on 16 September 1957; FDA authorised it on 6 January 1958; FDA has authorised it.

Who is the marketing authorisation holder for TRIFLUPROMAZINE HYDROCHLORIDE in United States?

BRISTOL MYERS SQUIBB holds the US marketing authorisation.