FDA — authorised 8 May 1942
- Application: NDA004782
- Marketing authorisation holder: WYETH PHARMS
- Local brand name: PREMARIN
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Vaginal conjugated estrogen cream 0.5gm in United States
FDA authorised Vaginal conjugated estrogen cream 0.5gm on 8 May 1942
Marketing authorisations
FDA — authorised 18 December 1956
- Application: NDA010402
- Marketing authorisation holder: WYETH PHARMS
- Local brand name: PREMARIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 October 1978
- Application: NDA020216
- Marketing authorisation holder: WYETH PHARMS
- Local brand name: PREMARIN
- Indication: CREAM — TOPICAL, VAGINAL
- Status: approved
FDA — authorised 16 July 2003
- Application: NDA021417
- Marketing authorisation holder: WYETH PHARMS INC
- Local brand name: PREMARIN
- Indication: TABLET — ORAL
- Status: approved
Other Women's Health approved in United States
Frequently asked questions
Is Vaginal conjugated estrogen cream 0.5gm approved in United States?
Yes. FDA authorised it on 8 May 1942; FDA authorised it on 18 December 1956; FDA authorised it on 16 October 1978.
Who is the marketing authorisation holder for Vaginal conjugated estrogen cream 0.5gm in United States?
WYETH PHARMS holds the US marketing authorisation.