FDA — authorised 8 May 1942
- Marketing authorisation holder: WYETH PHARMS INC
- Status: approved
🇺🇸 Premarin in United States
FDA authorised Premarin on 8 May 1942
Marketing authorisations
FDA — authorised 8 August 1997
- Application: NDA020527
- Marketing authorisation holder: WYETH PHARMS
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 4 December 1998
- Application: NDA020216
- Marketing authorisation holder: WYETH PHARMS
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 30 August 2005
- Application: NDA010402
- Marketing authorisation holder: WYETH PHARMS
- Indication: Labeling
- Status: approved
FDA — authorised 18 December 2019
- Application: NDA022247
- Marketing authorisation holder: WYETH PHARMS
- Indication: Labeling
- Status: approved
FDA — authorised 15 October 2025
- Application: ANDA214023
- Marketing authorisation holder: NOVAST LABS
- Local brand name: CONJUGATED ESTROGENS
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 October 2025
- Application: ANDA214025
- Marketing authorisation holder: NOVAST LABS
- Local brand name: CONJUGATED ESTROGENS
- Indication: TABLET — ORAL
- Status: approved
Premarin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Premarin approved in United States?
Yes. FDA authorised it on 8 May 1942; FDA authorised it on 8 August 1997; FDA authorised it on 4 December 1998.
Who is the marketing authorisation holder for Premarin in United States?
WYETH PHARMS INC holds the US marketing authorisation.