FDA — authorised 11 September 1997
- Marketing authorisation holder: SANOFI AVENTIS US
- Status: approved
🇺🇸 Anzemet in United States
FDA authorised Anzemet on 11 September 1997
Marketing authorisations
FDA — authorised 11 September 1997
- Application: NDA020623
- Marketing authorisation holder: VALIDUS PHARMS
- Local brand name: ANZEMET
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 September 1997
- Application: NDA020624
- Marketing authorisation holder: VALIDUS PHARMS
- Local brand name: ANZEMET
- Indication: INJECTABLE — INJECTION
- Status: approved
Anzemet in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Anzemet approved in United States?
Yes. FDA authorised it on 11 September 1997; FDA authorised it on 11 September 1997; FDA authorised it on 11 September 1997.
Who is the marketing authorisation holder for Anzemet in United States?
SANOFI AVENTIS US holds the US marketing authorisation.