FDA — authorised 19 May 1977
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Status: approved
🇺🇸 Ogen .625 in United States
FDA authorised Ogen .625 on 19 May 1977
Marketing authorisations
FDA — authorised 19 May 1977
- Application: ANDA083220
- Marketing authorisation holder: PFIZER
- Local brand name: OGEN .625
- Indication: TABLET — ORAL
- Status: approved
Ogen .625 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 Ogen .625 approved in United States?
Yes. FDA authorised it on 19 May 1977; FDA authorised it on 19 May 1977.
Who is the marketing authorisation holder for Ogen .625 in United States?
PHARMACIA AND UPJOHN holds the US marketing authorisation.