FDA — authorised 9 September 1987
- Application: ANDA089386
- Marketing authorisation holder: ESI
- Local brand name: CYCRIN
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Medroxyprogesterone 17-Acetate in United States
FDA authorised Medroxyprogesterone 17-Acetate on 9 September 1987
Marketing authorisations
FDA — authorised 30 October 1992
- Application: ANDA081239
- Marketing authorisation holder: ESI
- Local brand name: CYCRIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 October 1992
- Application: ANDA081240
- Marketing authorisation holder: ESI
- Local brand name: CYCRIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 December 1994
- Application: NDA020303
- Marketing authorisation holder: WYETH PHARMS INC
- Local brand name: PREMPRO (PREMARIN;CYCRIN)
- Indication: TABLET — ORAL-28
- Status: approved
Frequently asked questions
Is Medroxyprogesterone 17-Acetate approved in United States?
Yes. FDA authorised it on 9 September 1987; FDA authorised it on 30 October 1992; FDA authorised it on 30 October 1992.
Who is the marketing authorisation holder for Medroxyprogesterone 17-Acetate in United States?
ESI holds the US marketing authorisation.