FDA — authorised 20 April 1977
- Application: ANDA085007
- Marketing authorisation holder: PVT FORM
- Local brand name: FEMOGEN
- Indication: TABLET — ORAL
- Status: approved
FDA authorised ESTROGENS, ESTERIFIED on 20 April 1977
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 20 April 1977; FDA authorised it on 20 April 1977; FDA authorised it on 28 September 1977.
PVT FORM holds the US marketing authorisation.