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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
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US Army
US Department of Justice
Mallinckrodt
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Cantor Fitzgerald
Argus Health

Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020364

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NDA 020364 describes LOTREL, which is a drug marketed by Novartis and is included in one NDA. It is available from eight suppliers. 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. Twenty-four suppliers are listed for this compound. Additional details are available on the amlodipine besylate; benazepril hydrochloride profile page.
Summary for 020364
Tradename:LOTREL
Applicant:Novartis
Ingredient:amlodipine besylate; benazepril hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020364
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 N 0078-0364-05
LOTREL amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 020364 NDA Novartis Pharmaceuticals Corporation 0078-0379 N 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
Novartis LOTREL amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 020364-003 Mar 3, 1995 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis LOTREL amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 020364-002 Mar 3, 1995 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis LOTREL amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 020364-002 Mar 3, 1995 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis LOTREL amlodipine besylate; benazepril hydrochloride CAPSULE;ORAL 020364-005 Jun 20, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Colorcon
Baxter
Deloitte
Fuji
Mallinckrodt
Daiichi Sankyo
Julphar
US Army

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