FDA — authorised 17 May 1976
- Application: NDA008114
- Marketing authorisation holder: SCHERING
- Local brand name: PRANTAL
- Indication: TABLET — ORAL
- Status: approved
FDA authorised DIPHEMANIL METHYLSULFATE on 17 May 1976
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 17 May 1976; FDA has authorised it.
SCHERING holds the US marketing authorisation.