FDA — authorised 27 November 1991
- Application: NDA020076
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: HABITROL
- Indication: FILM, EXTENDED RELEASE — TRANSDERMAL
- Status: approved
FDA authorised Transdermal Nicoderm patch on 27 November 1991
Yes. FDA authorised it on 27 November 1991.
DR REDDYS LABS SA holds the US marketing authorisation.