🇺🇸 DOXAPRAM HYDROCHLORIDE in United States

FDA authorised DOXAPRAM HYDROCHLORIDE on 30 January 1992 · 21 US adverse-event reports

Marketing authorisations

FDA — authorised 30 January 1992

  • Application: ANDA073529
  • Marketing authorisation holder: WATSON LABS
  • Local brand name: DOXAPRAM HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 10 January 2003

  • Application: ANDA076266
  • Marketing authorisation holder: CHARTWELL INJECTABLE
  • Local brand name: DOXAPRAM HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

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. Hypokalaemia — 5 reports (23.81%)
  2. Depressed Level Of Consciousness — 3 reports (14.29%)
  3. Respiratory Failure — 3 reports (14.29%)
  4. Hepatic Failure — 2 reports (9.52%)
  5. Hepatitis Fulminant — 2 reports (9.52%)
  6. Respiratory Depression — 2 reports (9.52%)
  7. Acidosis — 1 report (4.76%)
  8. Anuria — 1 report (4.76%)
  9. Atelectasis — 1 report (4.76%)
  10. Decreased Appetite — 1 report (4.76%)

Source database →

DOXAPRAM 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 DOXAPRAM HYDROCHLORIDE approved in United States?

Yes. FDA authorised it on 30 January 1992; FDA authorised it on 10 January 2003; FDA has authorised it.

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

WATSON LABS holds the US marketing authorisation.