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
🇺🇸 Habitrol in United States
FDA authorised Habitrol on 27 November 1991
Marketing authorisations
FDA — authorised 29 December 2008
- Application: ANDA078697
- Marketing authorisation holder: P AND L
- Status: supplemented
FDA — authorised 29 December 2008
- Application: ANDA078699
- Marketing authorisation holder: P AND L
- Status: supplemented
FDA — authorised 8 July 2009
- Application: ANDA079044
- Marketing authorisation holder: P AND L
- Status: supplemented
FDA — authorised 8 July 2009
- Application: ANDA079038
- Marketing authorisation holder: P AND L
- Status: supplemented
FDA
- Status: approved
Other Other approved in United States
Frequently asked questions
Is Habitrol approved in United States?
Yes. FDA authorised it on 27 November 1991; FDA authorised it on 29 December 2008; FDA authorised it on 29 December 2008.
Who is the marketing authorisation holder for Habitrol in United States?
DR REDDYS LABS SA holds the US marketing authorisation.