FDA — authorised 16 May 1991
- Status: approved
🇺🇸 Monopril in United States
FDA authorised Monopril on 16 May 1991
Marketing authorisations
FDA — authorised 16 May 1991
- Application: NDA019915
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Local brand name: MONOPRIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 April 2005
- Application: ANDA077222
- Marketing authorisation holder: INVAGEN PHARMS
- Status: approved
FDA — authorised 30 March 2011
- Application: ANDA091163
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Status: approved
FDA — authorised 31 December 2013
- Application: ANDA076483
- Marketing authorisation holder: CHARTWELL RX
- Indication: Labeling
- Status: approved
FDA — authorised 3 January 2014
- Application: ANDA079245
- Marketing authorisation holder: AUROBINDO PHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 14 September 2015
- Application: ANDA090228
- Marketing authorisation holder: INVAGEN PHARMS
- Indication: Labeling
- Status: approved
Monopril 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 Monopril approved in United States?
Yes. FDA authorised it on 16 May 1991; FDA authorised it on 16 May 1991; FDA authorised it on 20 April 2005.
Who is the marketing authorisation holder for Monopril in United States?
Marketing authorisation holder not available in our data.