FDA — authorised 12 July 2002
- Application: NDA021282
- Marketing authorisation holder: RB HLTH
- Local brand name: MUCINEX
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA authorised Guafenesin tablets on 12 July 2002
Yes. FDA authorised it on 12 July 2002.
RB HLTH holds the US marketing authorisation.