FDA — authorised 31 October 1956
- Application: NDA010686
- Marketing authorisation holder: PFIZER
- Local brand name: MODERIL
- Indication: TABLET — ORAL
- Status: approved
FDA authorised Moderil on 31 October 1956
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 31 October 1956; FDA has authorised it; FDA has authorised it.
PFIZER holds the US marketing authorisation.