FDA — authorised 30 October 1981
- Application: NDA018333
- Marketing authorisation holder: ABBVIE
- Local brand name: CARAFATE
- Indication: TABLET — ORAL
- Status: approved
FDA authorised Carafate on 30 October 1981
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 30 October 1981; FDA has authorised it.
ABBVIE holds the US marketing authorisation.