🇺🇸 PROGESTERONE in United States

FDA authorised PROGESTERONE on 11 May 1978 · 12,070 US adverse-event reports

Marketing authorisations

FDA — authorised 11 May 1978

  • Application: NDA017362
  • Marketing authorisation holder: ACTAVIS LABS UT INC
  • Status: supplemented

FDA — authorised 28 October 2010

  • Application: ANDA091033
  • Marketing authorisation holder: HIKMA FARMACEUTICA
  • Status: approved

FDA — authorised 28 September 2012

  • Application: ANDA200456
  • Marketing authorisation holder: SOFGEN PHARMS
  • Status: supplemented

FDA — authorised 28 February 2017

  • Application: ANDA208801
  • Marketing authorisation holder: DR REDDYS
  • Status: supplemented

FDA — authorised 7 September 2017

  • Application: ANDA207724
  • Marketing authorisation holder: AMNEAL PHARMS NY
  • 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. Headache — 1,720 reports (14.25%)
  2. Off Label Use — 1,590 reports (13.17%)
  3. Drug Ineffective — 1,566 reports (12.97%)
  4. Fatigue — 1,518 reports (12.58%)
  5. Nausea — 1,241 reports (10.28%)
  6. Pain — 1,218 reports (10.09%)
  7. Exposure During Pregnancy — 826 reports (6.84%)
  8. Rash — 826 reports (6.84%)
  9. Dizziness — 814 reports (6.74%)
  10. Maternal Exposure During Pregnancy — 751 reports (6.22%)

Source database →

PROGESTERONE 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 PROGESTERONE approved in United States?

Yes. FDA authorised it on 11 May 1978; FDA authorised it on 28 October 2010; FDA authorised it on 28 September 2012.

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

ACTAVIS LABS UT INC holds the US marketing authorisation.