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Generated: May 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018602

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NDA 018602 describes CARDIZEM, which is a drug marketed by Biovail, Biovail Labs Intl, and Valeant Intl, and is included in six NDAs. It is available from seven suppliers. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the CARDIZEM profile page.

The generic ingredient in CARDIZEM is diltiazem hydrochloride. There are twenty-six drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.
Summary for 018602
Tradename:CARDIZEM
Applicant:Valeant Intl
Ingredient:diltiazem hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 018602
Mechanism of ActionCalcium Channel Antagonists
Suppliers and Packaging for NDA: 018602
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARDIZEM diltiazem hydrochloride TABLET;ORAL 018602 NDA Valeant Pharmaceuticals North America LLC 0187-0771 N 0187-0771-47
CARDIZEM diltiazem hydrochloride TABLET;ORAL 018602 NDA Valeant Pharmaceuticals North America LLC 0187-0771 N 0187-0771-55

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:Nov 5, 1982TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength60MG
Approval Date:Nov 5, 1982TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength90MG
Approval Date:Dec 8, 1986TE:ABRLD:Yes

Expired US Patents for NDA 018602

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Intl CARDIZEM diltiazem hydrochloride TABLET;ORAL 018602-003 Dec 8, 1986 ➤ Try a Free Trial ➤ Try a Free Trial
Valeant Intl CARDIZEM diltiazem hydrochloride TABLET;ORAL 018602-001 Nov 5, 1982 ➤ Try a Free Trial ➤ Try a Free Trial
Valeant Intl CARDIZEM diltiazem hydrochloride TABLET;ORAL 018602-004 Dec 8, 1986 ➤ Try a Free Trial ➤ Try a Free Trial
Valeant Intl CARDIZEM diltiazem hydrochloride TABLET;ORAL 018602-004 Dec 8, 1986 ➤ 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:

US Department of Justice
Healthtrust
Citi
QuintilesIMS
Deloitte
Federal Trade Commission
Dow
Express Scripts
Accenture

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