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Last Updated: April 27, 2024

Details for New Drug Application (NDA): 020364

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

The generic ingredient in LOTREL is amlodipine besylate; benazepril hydrochloride. There are fifty drug master file entries for this compound. Fifteen 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

Pharmacology for NDA: 020364

Mechanism of Action	Angiotensin-converting Enzyme Inhibitors Calcium Channel Antagonists Cytochrome P450 3A Inhibitors
Physiological Effect	Decreased Blood Pressure

Suppliers and Packaging for NDA: 020364

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364	NDA	Novartis Pharmaceuticals Corporation	0078-0364	0078-0364-05	100 CAPSULE in 1 BOTTLE (0078-0364-05)
LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364	NDA	Novartis Pharmaceuticals Corporation	0078-0379	0078-0379-05	100 CAPSULE in 1 BOTTLE (0078-0379-05)

Profile for product number 002

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

Profile for product number 003

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

Profile for product number 004

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 5MG BASE;20MG
Approval Date:	Mar 3, 1995	TE:	AB	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	⤷ Try a Trial	⤷ Try a Trial
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-003	Mar 3, 1995	⤷ Try a Trial	⤷ Try a Trial
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-002	Mar 3, 1995	⤷ Try a Trial	⤷ Try a Trial
Sandoz	LOTREL	amlodipine besylate; benazepril hydrochloride	CAPSULE;ORAL	020364-005	Jun 20, 2002	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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