FDA — authorised 13 September 1962
- Status: approved
🇺🇸 Uramustin in United States
FDA authorised Uramustin on 13 September 1962
Marketing authorisations
FDA — authorised 13 September 1962
- Application: NDA012892
- Marketing authorisation holder: SHIRE
- Local brand name: URACIL MUSTARD
- Indication: CAPSULE — ORAL
- Status: approved
Uramustin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Uramustin approved in United States?
Yes. FDA authorised it on 13 September 1962; FDA authorised it on 13 September 1962.
Who is the marketing authorisation holder for Uramustin in United States?
Marketing authorisation holder not available in our data.