Is there a generic for Amlodipine besylate; benazepril hydrochloride?

Yes. The FDA Orange Book lists 12 approved generic (ANDA) applications for Amlodipine besylate; benazepril hydrochloride, referencing the brand LOTREL. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Amlodipine besylate; benazepril hydrochloride?

LOTREL (NDA 020364, SANDOZ) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Amlodipine besylate; benazepril hydrochloride are approved?

Amlodipine besylate; benazepril hydrochloride is approved in the following dosage form: capsule.

FDA Orange Book · active-ingredient family

Amlodipine besylate; benazepril hydrochloride

Amlodipine besylate; 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:LOTREL · NDA 020364

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule

Product	Applicant	Application	TE	Approved
LOTRELRLD×6	SANDOZ	NDA 020364	—	Mar 03, 1995

Generic (ANDA) products (12)

Product	Applicant	Application	TE	Approved
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE×4	AMNEAL	ANDA 077215	—	Dec 07, 2018
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE×6	HERITAGE	ANDA 091431	AB	Dec 30, 2013
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE×6	AUROBINDO PHARMA LTD	ANDA 202239	AB	Sep 05, 2012
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE×2	DR REDDYS LABS INC	ANDA 090149	AB	Jul 05, 2011
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE×2	PHARMOBEDIENT	ANDA 079047	—	Jul 05, 2011
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE×2	WATSON LABS INC	ANDA 090364	AB	Jul 05, 2011
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE×4	WATSON LABS	ANDA 077890	AB	Oct 14, 2010
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE×6	CHARTWELL RX	ANDA 078381	—	Jul 29, 2010
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE×4	RISING	ANDA 077375	—	May 21, 2010
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE×4	DR REDDYS LABS INC	ANDA 077183	AB	Apr 15, 2010
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE×6	LUPIN PHARMS	ANDA 078466	AB	Feb 05, 2010
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE×6	TEVA PHARMS	ANDA 077179	—	May 18, 2007

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.

Amlodipine besylate; benazepril hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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