FDA — authorised 11 May 2001
- Application: NDA021098
- Marketing authorisation holder: BAYER HLTHCARE
- Local brand name: YASMIN
- Indication: TABLET — ORAL-28
- Status: approved
FDA authorised Oral contraceptives continuous on 11 May 2001
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 11 May 2001; FDA has authorised it.
BAYER HLTHCARE holds the US marketing authorisation.