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Last Updated: March 28, 2024

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 four suppliers. 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. Fifty 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:0
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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength120MG
Approval Date:Feb 6, 2003TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength180MG
Approval Date:Feb 6, 2003TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength240MG
Approval Date:Feb 6, 2003TE:ABRLD:Yes

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 021392-004 Feb 6, 2003 ⤷  Try a Trial ⤷  Try a Trial
Bausch CARDIZEM LA diltiazem hydrochloride TABLET, EXTENDED RELEASE;ORAL 021392-006 Feb 6, 2003 ⤷  Try a Trial ⤷  Try a Trial
Bausch CARDIZEM LA diltiazem hydrochloride TABLET, EXTENDED RELEASE;ORAL 021392-003 Feb 6, 2003 ⤷  Try a Trial ⤷  Try a Trial
Bausch CARDIZEM LA diltiazem hydrochloride TABLET, EXTENDED RELEASE;ORAL 021392-001 Feb 6, 2003 ⤷  Try a Trial ⤷  Try a Trial
Bausch CARDIZEM LA diltiazem hydrochloride TABLET, EXTENDED RELEASE;ORAL 021392-003 Feb 6, 2003 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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