Is Benazepril Hydrochloride still available?

Yes. Benazepril Hydrochloride (ANDA 078212) is listed with marketing status Prescription in the FDA Orange Book.

What is Benazepril Hydrochloride a generic of?

Benazepril Hydrochloride is a generic (ANDA 078212) containing Benazepril Hydrochloride. Open the active-ingredient family to see the reference-listed brand and other approved products.

What does Benazepril Hydrochloride's TE code AB mean?

AB is an "A"-rated therapeutic-equivalence code, meaning the FDA considers Benazepril Hydrochloride substitutable for its reference brand with no expected difference in clinical effect.

What is Benazepril Hydrochloride's FDA application number?

Benazepril Hydrochloride is approved under ANDA 078212, held by Aurobindo Pharma.

Orange Book product · Generic (ANDA)

Benazepril Hydrochloride

Generic (ANDA)ANDA 078212TE AB Aurobindo Pharma

Approved

May 22, 2008

Application

Generic (ANDA)

TE code

Listed patents

Benazepril Hydrochloride (Benazepril Hydrochloride) is a generic drug approved under an ANDA (078212) in 2008, marketed by Aurobindo Pharma. Its therapeutic-equivalence code is AB, so the FDA considers it substitutable for the reference brand.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Approval
FDA approval date of this drug product.
May 22, 2008
18 yr 5 mo ago
Today

FDA product record

Pharmaceutical detail

Active ingredient

BENAZEPRIL HYDROCHLORIDE

Strength

40MG

Dosage form

TABLET

Route

ORAL

TE code

Application

ANDA 078212

Product number

003

Marketing status

Prescription

Reference listed drug (RLD)

Reference standard (RS)

Yes

Same application

Other strengths in ANDA 078212

Brand + generics

Active-ingredient family

Generic (ANDA) of Benazepril Hydrochloride

View full Benazepril Hydrochloride family

Orange Book patent file

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.

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