Benazepril Hydrochloride
Benazepril Hydrochloride
Sourced from the FDA Orange Book
Key dates
Key dates
Approval
FDA approval date of this drug product.
May 22, 2008
18 yr 5 mo ago
Today
Pharmaceutical detail
Pharmaceutical detail
Active ingredient
BENAZEPRIL HYDROCHLORIDE
Strength
40MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 078212
Product number
003
Marketing status
Prescription
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Other strengths in ANDA 078212
Active-ingredient family
Generic (ANDA) of Benazepril Hydrochloride
- 1991LotensinBrand (NDA)
NDA 019851 · Validus Pharms
- 2008Benazepril HydrochlorideGeneric (ANDA)
ANDA 078848 · Zydus Lifesciences
- 2006Benazepril HydrochlorideGeneric (ANDA)
ANDA 077128 · Corepharma
- 2006Benazepril HydrochlorideGeneric (ANDA)
ANDA 076820 · Amneal Pharms
- 2004Benazepril HydrochlorideGeneric (ANDA)
ANDA 076333 · Ani Pharms
- 2004Benazepril HydrochlorideGeneric (ANDA)
ANDA 076402 · Chartwell Rx
- 2004Benazepril HydrochlorideGeneric (ANDA)
ANDA 076476 · Genpharm
- 2004Benazepril HydrochlorideGeneric (ANDA)
ANDA 076267 · Heritage Pharma
- 2004Benazepril HydrochlorideGeneric (ANDA)
ANDA 076118 · Prinston Inc
- 2004Benazepril HydrochlorideGeneric (ANDA)
ANDA 076430 · Rising
- 2004Benazepril HydrochlorideGeneric (ANDA)
ANDA 076344 · Sun Pharm Inds Ltd
- 2004Benazepril HydrochlorideGeneric (ANDA)
ANDA 076211 · Teva
Listed patents
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
Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.
Built directly from the FDA Orange Book data file. This product page links back to the Benazepril Hydrochloride active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.

