FDA — authorised 24 October 2005
- Application: ANDA076549
- Marketing authorisation holder: WATSON LABS
- Local brand name: RAMIPRIL
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 ACEI omission in United States
FDA authorised ACEI omission on 24 October 2005
Marketing authorisations
FDA — authorised 9 June 2008
- Application: ANDA077626
- Marketing authorisation holder: LUPIN
- Local brand name: RAMIPRIL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 June 2008
- Application: ANDA077470
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: RAMIPRIL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 20 June 2008
- Application: ANDA079116
- Marketing authorisation holder: COREPHARMA
- Local brand name: RAMIPRIL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 2 September 2008
- Application: ANDA078832
- Marketing authorisation holder: ZYDUS PHARMS USA
- Local brand name: RAMIPRIL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 6 March 2009
- Application: ANDA078849
- Marketing authorisation holder: RANBAXY LABS LTD
- Local brand name: RAMIPRIL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 8 June 2011
- Application: ANDA091604
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: RAMIPRIL
- Indication: CAPSULE — ORAL
- Status: approved
Other Cardiovascular approved in United States
Frequently asked questions
Is ACEI omission approved in United States?
Yes. FDA authorised it on 24 October 2005; FDA authorised it on 9 June 2008; FDA authorised it on 18 June 2008.
Who is the marketing authorisation holder for ACEI omission in United States?
WATSON LABS holds the US marketing authorisation.