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Last Updated: October 6, 2022

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 Bausch, and is included in six NDAs. It is available from five suppliers. 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-two suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.
Summary for 018602
Tradename:CARDIZEM
Applicant:Bausch
Ingredient:diltiazem hydrochloride
Patents:0
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 Bausch Health US LLC 0187-0771 0187-0771-47 100 TABLET, COATED in 1 BOTTLE (0187-0771-47)
CARDIZEM diltiazem hydrochloride TABLET;ORAL 018602 NDA Bausch Health US LLC 0187-0772 0187-0772-47 100 TABLET, COATED in 1 BOTTLE (0187-0772-47)

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

Expired US Patents for NDA 018602

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bausch CARDIZEM diltiazem hydrochloride TABLET;ORAL 018602-004 Dec 8, 1986 See Plans and Pricing See Plans and Pricing
Bausch CARDIZEM diltiazem hydrochloride TABLET;ORAL 018602-001 Nov 5, 1982 See Plans and Pricing See Plans and Pricing
Bausch CARDIZEM diltiazem hydrochloride TABLET;ORAL 018602-004 Dec 8, 1986 See Plans and Pricing See Plans and Pricing
Bausch CARDIZEM diltiazem hydrochloride TABLET;ORAL 018602-003 Dec 8, 1986 See Plans and Pricing See Plans and Pricing
Bausch CARDIZEM diltiazem hydrochloride TABLET;ORAL 018602-002 Nov 5, 1982 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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