FDA — authorised 14 November 2003
- Application: NDA021490
- Marketing authorisation holder: APIL
- Local brand name: FEMCON FE
- Indication: TABLET — ORAL
- Status: approved
FDA authorised Ovcon® 35 Fe on 14 November 2003
Yes. FDA authorised it on 14 November 2003.
APIL holds the US marketing authorisation.