FDA — authorised 30 May 1973
- Application: ANDA083003
- Marketing authorisation holder: TABLICAPS
- Local brand name: STILBESTROL
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA authorised Estrobene on 30 May 1973
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 May 1973; FDA has authorised it; FDA has authorised it.
TABLICAPS holds the US marketing authorisation.