FDA — authorised 16 April 2014
- Application: ANDA200910
- Marketing authorisation holder: MYLAN TECHNOLOGIES
- Local brand name: XULANE
- Indication: FILM, EXTENDED RELEASE — TRANSDERMAL
- Status: approved
FDA authorised Transdermal Contraceptive on 16 April 2014
Yes. FDA authorised it on 16 April 2014.
MYLAN TECHNOLOGIES holds the US marketing authorisation.