FDA — authorised 14 September 1963
- Application: NDA013601
- Marketing authorisation holder: APOTHECON
- Local brand name: MUCOMYST
- Indication: SOLUTION — INHALATION, ORAL
- Status: approved
FDA authorised n-acetylcystine + albuterol on 14 September 1963
Yes. FDA authorised it on 14 September 1963.
APOTHECON holds the US marketing authorisation.