Last Updated: November 10, 2026

Details for New Drug Application (NDA): 020364

NDA 020364 describes LOTREL, which is a drug marketed by Sandoz and is included in one NDA. Additional details are available on the LOTREL profile page.

The generic ingredient in LOTREL is amlodipine besylate; benazepril hydrochloride. There is one drug master file entry for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the amlodipine besylate; benazepril hydrochloride profile page.

Summary for 020364

Tradename:	LOTREL
Applicant:	Sandoz
Ingredient:	amlodipine besylate; benazepril hydrochloride
Patents:	0

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 2.5MG BASE;10MG
Approval Date:	Mar 3, 1995	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 5MG BASE;10MG
Approval Date:	Mar 3, 1995	TE:		RLD:	Yes

Profile for product number 004

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 5MG BASE;20MG
Approval Date:	Mar 3, 1995	TE:		RLD:	Yes

Expired US Patents for NDA 020364

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-004	Mar 3, 1995	⤷ Start Trial	⤷ Start Trial
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-002	Mar 3, 1995	⤷ Start Trial	⤷ Start Trial
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-003	Mar 3, 1995	⤷ Start Trial	⤷ Start Trial
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-006	Apr 11, 2006	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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