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Serving leading biopharmaceutical companies globally:

Accenture
Merck
Dow
Covington
Farmers Insurance
Queensland Health
McKinsey
Moodys
Colorcon
Johnson and Johnson

Generated: December 17, 2017

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 four 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:1
Applicant:1
Ingredient:1
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 0187-0771-55 500 TABLET, COATED in 1 BOTTLE (0187-0771-55)
CARDIZEM diltiazem hydrochloride TABLET;ORAL 018602 NDA Valeant Pharmaceuticals North America LLC 0187-0771 0187-0771-47 100 TABLET, COATED in 1 BOTTLE (0187-0771-47)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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

Expired Orange Book Patents for NDA: 018602

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant IntlCARDIZEMdiltiazem hydrochlorideTABLET;ORAL018602-001Nov 5, 1982► Subscribe► Subscribe
Valeant IntlCARDIZEMdiltiazem hydrochlorideTABLET;ORAL018602-004Dec 8, 1986► Subscribe► Subscribe
Valeant IntlCARDIZEMdiltiazem hydrochlorideTABLET;ORAL018602-004Dec 8, 1986► Subscribe► Subscribe
Valeant IntlCARDIZEMdiltiazem hydrochlorideTABLET;ORAL018602-004Dec 8, 1986► Subscribe► Subscribe
Valeant IntlCARDIZEMdiltiazem hydrochlorideTABLET;ORAL018602-003Dec 8, 1986► Subscribe► Subscribe
Valeant IntlCARDIZEMdiltiazem hydrochlorideTABLET;ORAL018602-002Nov 5, 1982► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Dow
Cipla
Deloitte
Moodys
Accenture
Cantor Fitzgerald
Cerilliant
McKesson
Healthtrust

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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