FDA — authorised 22 November 1997
- Application: NDA020632
- Marketing authorisation holder: ABBOTT
- Local brand name: MERIDIA
- Indication: CAPSULE — ORAL
- Status: approved
FDA authorised sibutramine hydochloride monohydrate on 22 November 1997
Yes. FDA authorised it on 22 November 1997.
ABBOTT holds the US marketing authorisation.