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Generated: November 14, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021392

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NDA 021392 describes CARDIZEM LA, which is a drug marketed by Valeant Intl and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the CARDIZEM LA profile page.

The generic ingredient in CARDIZEM LA is diltiazem hydrochloride. There are twenty-six drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.
Summary for 021392
Tradename:CARDIZEM LA
Applicant:Valeant Intl
Ingredient:diltiazem hydrochloride
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 021392
Mechanism of ActionCalcium Channel Antagonists
Suppliers and Packaging for NDA: 021392
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARDIZEM LA diltiazem hydrochloride TABLET, EXTENDED RELEASE;ORAL 021392 NDA Valeant Pharmaceuticals North America LLC 0187-2045 0187-2045-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-2045-30)
CARDIZEM LA diltiazem hydrochloride TABLET, EXTENDED RELEASE;ORAL 021392 NDA Valeant Pharmaceuticals North America LLC 0187-2045 0187-2045-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-2045-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength120MG
Approval Date:Feb 6, 2003TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Feb 25, 2021Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Dec 17, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF HYPERTENSION AND ANGINA PECTORIS

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength180MG
Approval Date:Feb 6, 2003TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Feb 25, 2021Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021392

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Intl CARDIZEM LA diltiazem hydrochloride TABLET, EXTENDED RELEASE;ORAL 021392-001 Feb 6, 2003 ➤ Sign Up ➤ Sign Up
Valeant Intl CARDIZEM LA diltiazem hydrochloride TABLET, EXTENDED RELEASE;ORAL 021392-003 Feb 6, 2003 ➤ Sign Up ➤ Sign Up
Valeant Intl CARDIZEM LA diltiazem hydrochloride TABLET, EXTENDED RELEASE;ORAL 021392-006 Feb 6, 2003 ➤ Sign Up ➤ Sign Up
Valeant Intl CARDIZEM LA diltiazem hydrochloride TABLET, EXTENDED RELEASE;ORAL 021392-005 Feb 6, 2003 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

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