FDA — authorised 11 February 2004
- Application: ANDA076688
- Marketing authorisation holder: AUROBINDO PHARMA USA
- Local brand name: BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 BENAZEPRIL HYDROCHLORIDE in United States
FDA authorised BENAZEPRIL HYDROCHLORIDE on 11 February 2004
Marketing authorisations
FDA — authorised 11 February 2004
- Application: ANDA076631
- Marketing authorisation holder: SANDOZ
- Local brand name: BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 February 2004
- Application: ANDA076348
- Marketing authorisation holder: ANI PHARMS
- Local brand name: BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 February 2004
- Application: ANDA076344
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: BENAZEPRIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 February 2004
- Application: ANDA076342
- Marketing authorisation holder: ANI PHARMS
- Local brand name: BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 February 2004
- Application: ANDA076476
- Marketing authorisation holder: GENPHARM
- Local brand name: BENAZEPRIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 February 2004
- Application: ANDA076211
- Marketing authorisation holder: TEVA
- Local brand name: BENAZEPRIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 February 2004
- Application: ANDA076402
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: BENAZEPRIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 February 2004
- Application: ANDA076333
- Marketing authorisation holder: ANI PHARMS
- Local brand name: BENAZEPRIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 February 2004
- Application: ANDA076267
- Marketing authorisation holder: HERITAGE PHARMA
- Local brand name: BENAZEPRIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 February 2004
- Application: ANDA076118
- Marketing authorisation holder: PRINSTON INC
- Local brand name: BENAZEPRIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 February 2004
- Application: ANDA076612
- Marketing authorisation holder: MYLAN PHARMS INC
- Local brand name: BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 September 2005
- Application: ANDA077483
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 February 2006
- Application: ANDA076820
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: BENAZEPRIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 March 2006
- Application: ANDA077128
- Marketing authorisation holder: COREPHARMA
- Local brand name: BENAZEPRIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 May 2008
- Application: ANDA078212
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: BENAZEPRIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 May 2008
- Application: ANDA078848
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: BENAZEPRIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 February 2010
- Application: ANDA078466
- Marketing authorisation holder: LUPIN PHARMS
- Status: supplemented
FDA — authorised 15 April 2010
- Application: ANDA077183
- Marketing authorisation holder: DR REDDYS LABS INC
- Status: supplemented
FDA
- Status: approved
BENAZEPRIL HYDROCHLORIDE 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 BENAZEPRIL HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 11 February 2004; FDA authorised it on 11 February 2004; FDA authorised it on 11 February 2004.
Who is the marketing authorisation holder for BENAZEPRIL HYDROCHLORIDE in United States?
AUROBINDO PHARMA USA holds the US marketing authorisation.