FDA Orange Book · active-ingredient family
Benazepril hydrochloride
Benazepril hydrochloride is approved as 1 brand and 12 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:LOTENSIN · NDA 019851
1
Brand (NDA)
12
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LOTENSINRLD×4 | VALIDUS PHARMS | NDA 019851 | — | Jun 25, 1991 |
Generic (ANDA) products (12)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BENAZEPRIL HYDROCHLORIDE×4 | ZYDUS LIFESCIENCES | ANDA 078848 | AB | May 23, 2008 | |
| BENAZEPRIL HYDROCHLORIDE×3 | AUROBINDO PHARMA | ANDA 078212 | AB | May 22, 2008 | |
| BENAZEPRIL HYDROCHLORIDE×4 | COREPHARMA | ANDA 077128 | AB | Mar 08, 2006 | |
| BENAZEPRIL HYDROCHLORIDE×4 | AMNEAL PHARMS | ANDA 076820 | AB | Feb 03, 2006 | |
| BENAZEPRIL HYDROCHLORIDE×4 | ANI PHARMS | ANDA 076333 | AB | Feb 11, 2004 | |
| BENAZEPRIL HYDROCHLORIDE×4 | CHARTWELL RX | ANDA 076402 | AB | Feb 11, 2004 | |
| BENAZEPRIL HYDROCHLORIDE×4 | GENPHARM | ANDA 076476 | — | Feb 11, 2004 | |
| BENAZEPRIL HYDROCHLORIDE×4 | HERITAGE PHARMA | ANDA 076267 | AB | Feb 11, 2004 | |
| BENAZEPRIL HYDROCHLORIDE×4 | PRINSTON INC | ANDA 076118 | AB | Feb 11, 2004 | |
| BENAZEPRIL HYDROCHLORIDE×4 | RISING | ANDA 076430 | — | Feb 11, 2004 | |
| BENAZEPRIL HYDROCHLORIDE×4 | SUN PHARM INDS LTD | ANDA 076344 | AB | Feb 11, 2004 | |
| BENAZEPRIL HYDROCHLORIDE×4 | TEVA | ANDA 076211 | 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 — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
