FDA — authorised 19 November 1991
- Application: NDA019885
- Marketing authorisation holder: PFIZER PHARMS
- Local brand name: ACCUPRIL
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Accupril in United States
FDA authorised Accupril on 19 November 1991
Marketing authorisations
FDA — authorised 19 November 1991
- Marketing authorisation holder: PFIZER PHARMS
- Status: approved
FDA — authorised 29 April 2013
- Application: ANDA202725
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Status: approved
FDA — authorised 26 November 2014
- Application: ANDA078450
- Marketing authorisation holder: AUROBINDO PHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 25 November 2015
- Application: ANDA078457
- Marketing authorisation holder: INVAGEN PHARMS
- Indication: Labeling
- Status: approved
FDA — authorised 1 November 2019
- Application: ANDA205823
- Marketing authorisation holder: PRINSTON INC
- Indication: Labeling
- Status: approved
FDA — authorised 6 November 2019
- Application: ANDA076374
- Marketing authorisation holder: CHARTWELL RX
- Indication: Labeling
- Status: approved
Accupril 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 Accupril approved in United States?
Yes. FDA authorised it on 19 November 1991; FDA authorised it on 19 November 1991; FDA authorised it on 29 April 2013.
Who is the marketing authorisation holder for Accupril in United States?
PFIZER PHARMS holds the US marketing authorisation.