FDA — authorised 27 December 1988
- Application: NDA019268
- Marketing authorisation holder: PFIZER
- Local brand name: CYTOTEC
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 misprostol in United States
FDA authorised misprostol on 27 December 1988
Marketing authorisation
Other Other approved in United States
Frequently asked questions
Is misprostol approved in United States?
Yes. FDA authorised it on 27 December 1988.
Who is the marketing authorisation holder for misprostol in United States?
PFIZER holds the US marketing authorisation.