FDA — authorised 22 May 2007
- Application: NDA021864
- Marketing authorisation holder: WYETH PHARMS INC
- Local brand name: LYBREL
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Lybrel in United States
FDA authorised Lybrel on 22 May 2007
Marketing authorisation
Other Other approved in United States
Frequently asked questions
Is Lybrel approved in United States?
Yes. FDA authorised it on 22 May 2007.
Who is the marketing authorisation holder for Lybrel in United States?
WYETH PHARMS INC holds the US marketing authorisation.