FDA — authorised 12 December 2006
- Application: ANDA077489
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: TRANDOLAPRIL
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 TRANDOLAPRIL in United States
FDA authorised TRANDOLAPRIL on 12 December 2006
Marketing authorisations
FDA — authorised 12 June 2007
- Application: ANDA077256
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: TRANDOLAPRIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 June 2007
- Application: ANDA077522
- Marketing authorisation holder: LUPIN
- Local brand name: TRANDOLAPRIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 June 2007
- Application: ANDA077805
- Marketing authorisation holder: WATSON LABS
- Local brand name: TRANDOLAPRIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 June 2007
- Application: ANDA078438
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: TRANDOLAPRIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 June 2007
- Application: ANDA078320
- Marketing authorisation holder: INVAGEN PHARMS
- Local brand name: TRANDOLAPRIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 April 2008
- Application: ANDA078346
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: TRANDOLAPRIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 June 2008
- Application: ANDA078508
- Marketing authorisation holder: EPIC PHARMA
- Local brand name: TRANDOLAPRIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 May 2010
- Application: ANDA079135
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Status: approved
TRANDOLAPRIL in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is TRANDOLAPRIL approved in United States?
Yes. FDA authorised it on 12 December 2006; FDA authorised it on 12 June 2007; FDA authorised it on 12 June 2007.
Who is the marketing authorisation holder for TRANDOLAPRIL in United States?
TEVA PHARMS holds the US marketing authorisation.