FDA — authorised 18 October 1963
- Marketing authorisation holder: SCHERING PLOUGH
- Status: approved
🇺🇸 Drixoral in United States
FDA authorised Drixoral on 18 October 1963
Marketing authorisations
FDA — authorised 18 October 1963
- Application: NDA013483
- Marketing authorisation holder: SCHERING PLOUGH
- Local brand name: DRIXORAL
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
Drixoral in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Drixoral approved in United States?
Yes. FDA authorised it on 18 October 1963; FDA authorised it on 18 October 1963.
Who is the marketing authorisation holder for Drixoral in United States?
SCHERING PLOUGH holds the US marketing authorisation.