FDA — authorised 3 June 1971
- Marketing authorisation holder: DAVA PHARMS INC
- Status: approved
🇺🇸 Pyrazinamide in United States
FDA authorised Pyrazinamide on 3 June 1971
Marketing authorisations
FDA — authorised 30 June 1992
- Application: ANDA081319
- Marketing authorisation holder: HIKMA
- Local brand name: PYRAZINAMIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 May 1994
- Application: ANDA080157
- Marketing authorisation holder: NOVITIUM PHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 27 July 2020
- Application: ANDA212541
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: PYRAZINAMIDE
- Indication: TABLET — ORAL
- Status: approved
Pyrazinamide 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 Pyrazinamide approved in United States?
Yes. FDA authorised it on 3 June 1971; FDA authorised it on 30 June 1992; FDA authorised it on 23 May 1994.
Who is the marketing authorisation holder for Pyrazinamide in United States?
DAVA PHARMS INC holds the US marketing authorisation.