FDA — authorised 23 August 1977
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Status: approved
🇺🇸 Prepidil in United States
FDA authorised Prepidil on 23 August 1977
Marketing authorisations
FDA — authorised 9 December 1992
- Application: NDA019617
- Marketing authorisation holder: PFIZER
- Local brand name: PREPIDIL
- Indication: GEL — ENDOCERVICAL
- Status: approved
Prepidil in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Prepidil approved in United States?
Yes. FDA authorised it on 23 August 1977; FDA authorised it on 9 December 1992.
Who is the marketing authorisation holder for Prepidil in United States?
PHARMACIA AND UPJOHN holds the US marketing authorisation.