🇺🇸 PHENELZINE SULFATE in United States

FDA authorised PHENELZINE SULFATE on 9 June 1961 · 254 US adverse-event reports

Marketing authorisations

FDA — authorised 9 June 1961

  • Application: NDA011909
  • Marketing authorisation holder: PARKE DAVIS
  • Status: supplemented

FDA — authorised 8 December 2010

  • Application: ANDA200181
  • Marketing authorisation holder: NOVEL LABS INC
  • 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 Ineffective — 93 reports (36.61%)
  2. Depression — 30 reports (11.81%)
  3. Headache — 23 reports (9.06%)
  4. Drug Interaction — 20 reports (7.87%)
  5. Fatigue — 17 reports (6.69%)
  6. Feeling Abnormal — 17 reports (6.69%)
  7. Off Label Use — 15 reports (5.91%)
  8. Dizziness — 13 reports (5.12%)
  9. Insomnia — 13 reports (5.12%)
  10. Nausea — 13 reports (5.12%)

Source database →

PHENELZINE SULFATE 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 PHENELZINE SULFATE approved in United States?

Yes. FDA authorised it on 9 June 1961; FDA authorised it on 8 December 2010; FDA has authorised it.

Who is the marketing authorisation holder for PHENELZINE SULFATE in United States?

PARKE DAVIS holds the US marketing authorisation.