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Last Updated: July 7, 2020

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Details for New Drug Application (NDA): 021392


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NDA 021392 describes CARDIZEM LA, which is a drug marketed by Bausch and is included in one NDA. It is available from three suppliers. There is one patent 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. Thirty-seven suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.
Summary for 021392
Tradename:CARDIZEM LA
Applicant:Bausch
Ingredient:diltiazem hydrochloride
Patents:1
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 Bausch Health US 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 Bausch Health US LLC 0187-2045 0187-2045-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-2045-90)
Paragraph IV (Patent) Challenges for 021392
Tradename Dosage Ingredient NDA Submissiondate
CARDIZEM LA TABLET, EXTENDED RELEASE;ORAL diltiazem hydrochloride 021392 2005-08-30
CARDIZEM LA TABLET, EXTENDED RELEASE;ORAL diltiazem hydrochloride 021392 2005-04-25

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength120MG
Approval Date:Feb 6, 2003TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Feb 25, 2021Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

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

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength240MG
Approval Date:Feb 6, 2003TE:ABRLD:Yes
Patent:  Start TrialPatent 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
Bausch CARDIZEM LA diltiazem hydrochloride TABLET, EXTENDED RELEASE;ORAL 021392-006 Feb 6, 2003   Start Trial   Start Trial
Bausch CARDIZEM LA diltiazem hydrochloride TABLET, EXTENDED RELEASE;ORAL 021392-002 Feb 6, 2003   Start Trial   Start Trial
Bausch CARDIZEM LA diltiazem hydrochloride TABLET, EXTENDED RELEASE;ORAL 021392-001 Feb 6, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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