FDA — authorised 22 April 1998
- Application: NDA020713
- Marketing authorisation holder: TEVA BRANDED PHARM
- Local brand name: MIRCETTE
- Indication: TABLET — ORAL-28
- Status: approved
FDA authorised Mircette® on 22 April 1998
Yes. FDA authorised it on 22 April 1998.
TEVA BRANDED PHARM holds the US marketing authorisation.