FDA — authorised 31 July 1997
- Application: NDA020701
- Marketing authorisation holder: ABBVIE
- Indication: Type 3 - New Dosage Form
- Status: approved
🇺🇸 Endometrin in United States
FDA authorised Endometrin on 31 July 1997
Marketing authorisations
FDA — authorised 21 June 2007
- Application: NDA022057
- Marketing authorisation holder: FERRING
- Local brand name: ENDOMETRIN
- Indication: INSERT — VAGINAL
- Status: approved
FDA — authorised 28 September 2012
- Application: ANDA200456
- Marketing authorisation holder: SOFGEN PHARMS
- Indication: Not Applicable
- Status: approved
FDA — authorised 7 September 2017
- Application: ANDA207724
- Marketing authorisation holder: AMNEAL PHARMS NY
- Status: approved
FDA — authorised 22 June 2021
- Application: NDA210132
- Marketing authorisation holder: MAYNE PHARMA
- Indication: Labeling
- Status: approved
Endometrin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Women's Health approved in United States
Frequently asked questions
Is Endometrin approved in United States?
Yes. FDA authorised it on 31 July 1997; FDA authorised it on 21 June 2007; FDA authorised it on 28 September 2012.
Who is the marketing authorisation holder for Endometrin in United States?
ABBVIE holds the US marketing authorisation.