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Last Updated: November 21, 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
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:RXDosage:CAPSULE;ORALStrengthEQ 2.5MG BASE;10MG
Approval Date:Mar 3, 1995TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 5MG BASE;10MG
Approval Date:Mar 3, 1995TE:ABRLD:Yes

Profile for product number 004

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 5MG BASE;20MG
Approval Date:Mar 3, 1995TE:ABRLD:Yes

Expired US Patents for NDA 020364

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sandoz LOTREL amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 020364-005 Jun 20, 2002 ⤷  Sign Up ⤷  Sign Up
Sandoz LOTREL amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 020364-007 Apr 11, 2006 ⤷  Sign Up ⤷  Sign Up
Sandoz LOTREL amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 020364-004 Mar 3, 1995 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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