FDA — authorised 23 March 1966
- Application: NDA016029
- Marketing authorisation holder: GD SEARLE LLC
- Local brand name: OVULEN
- Indication: TABLET — ORAL-20
- Status: approved
🇺🇸 ETHYNODIOL DIACETATE in United States
FDA authorised ETHYNODIOL DIACETATE on 23 March 1966
Marketing authorisations
FDA — authorised 9 February 2016
- Application: ANDA204704
- Marketing authorisation holder: XIROMED
- Status: approved
FDA — authorised 28 July 2016
- Application: ANDA204703
- Marketing authorisation holder: XIROMED
- Status: supplemented
FDA
- Status: approved
ETHYNODIOL DIACETATE 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 ETHYNODIOL DIACETATE approved in United States?
Yes. FDA authorised it on 23 March 1966; FDA authorised it on 9 February 2016; FDA authorised it on 28 July 2016.
Who is the marketing authorisation holder for ETHYNODIOL DIACETATE in United States?
GD SEARLE LLC holds the US marketing authorisation.