FDA — authorised 4 December 1997
- Application: NDA020696
- Marketing authorisation holder: PAR PHARM INC
- Local brand name: ANTIZOL
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Antizol in United States
FDA authorised Antizol on 4 December 1997
Marketing authorisations
FDA — authorised 14 December 2007
- Application: ANDA078368
- Marketing authorisation holder: AM REGENT
- Local brand name: FOMEPIZOLE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 March 2008
- Application: ANDA078639
- Marketing authorisation holder: MYLAN INSTITUTIONAL
- Local brand name: FOMEPIZOLE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 6 March 2008
- Application: ANDA078537
- Marketing authorisation holder: NAVINTA LLC
- Local brand name: FOMEPIZOLE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
Antizol in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Antizol approved in United States?
Yes. FDA authorised it on 4 December 1997; FDA authorised it on 14 December 2007; FDA authorised it on 3 March 2008.
Who is the marketing authorisation holder for Antizol in United States?
PAR PHARM INC holds the US marketing authorisation.