FDA Orange Book · active-ingredient family
Benazepril hydrochloride; hydrochlorothiazide
Benazepril hydrochloride; hydrochlorothiazide is approved as 1 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:LOTENSIN HCT · NDA 020033
1
Brand (NDA)
7
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LOTENSIN HCTRLD×4 | VALIDUS PHARMS | NDA 020033 | — | May 19, 1992 |
Generic (ANDA) products (7)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE×4 | APOTEX | ANDA 078794 | — | Aug 21, 2014 | |
| BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE×4 | SUN PHARM INDS LTD | ANDA 077483 | — | Sep 08, 2005 | |
| BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE×4 | ANI PHARMS | ANDA 076342 | AB | Feb 11, 2004 | |
| BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE×4 | ANI PHARMS | ANDA 076348 | — | Feb 11, 2004 | |
| BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE×4 | AUROBINDO PHARMA USA | ANDA 076688 | — | Feb 11, 2004 | |
| BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE×4 | MYLAN PHARMS INC | ANDA 076612 | — | Feb 11, 2004 | |
| BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE×4 | SANDOZ | ANDA 076631 | AB | Feb 11, 2004 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Benazepril hydrochloride; hydrochlorothiazide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
