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CARDIZEM Drug Profile

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Cardizem is a drug marketed by Valeant Intl, Biovail Labs Intl, and Biovail. and is included in six NDAs. It is available from two suppliers. There are two patents protecting this drug and two Paragraph IV challenges.

The generic ingredient in CARDIZEM is diltiazem hydrochloride. There are twenty-six drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.

Summary for Tradename: CARDIZEM

Patents:2
Applicants:3
NDAs:6
Suppliers / Packagers: see list2
Drug Prices: :see details

Pharmacology for Tradename: CARDIZEM

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Biovail
CARDIZEM SR
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL019471-004Jan 23, 1989DISCNNo► subscribe► subscribe
Valeant Intl
CARDIZEM
diltiazem hydrochloride
TABLET;ORAL018602-001Nov 5, 1982RXNo► subscribe► subscribe
Valeant Intl
CARDIZEM LA
diltiazem hydrochloride
TABLET, EXTENDED RELEASE;ORAL021392-003Feb 6, 2003RXNo6,923,984► subscribeY ► subscribe
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Expired Patents for Tradename: CARDIZEM

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Intl
CARDIZEM
diltiazem hydrochloride
TABLET;ORAL018602-001Nov 5, 19823,562,257► subscribe
Valeant Intl
CARDIZEM
diltiazem hydrochloride
TABLET;ORAL018602-004Dec 8, 19863,778,506► subscribe
Valeant Intl
CARDIZEM
diltiazem hydrochloride
TABLET;ORAL018602-004Dec 8, 19863,562,257► subscribe
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Paragraph IV activity for: CARDIZEM

Drugname Dosage Strength RLD Submissiondate
diltiazem hydrochlorideExtended-release Tablets120 mg, 180 mg, 240 mg, 300 mg and 360 mgCardizem LA8/30/2005
diltiazem hydrochlorideExtended-release Tablets420 mgCardizem LA4/25/2005
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