FDA — authorised 17 November 1995
- Application: NDA020527
- Marketing authorisation holder: WYETH PHARMS
- Local brand name: PREMPHASE 14/14
- Indication: TABLET — ORAL-28
- Status: approved
FDA authorised Premarin on 17 November 1995
Yes. FDA authorised it on 17 November 1995; FDA has authorised it.
WYETH PHARMS holds the US marketing authorisation.