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 four 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. Fifty-four 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

Pharmacology for NDA: 018602

Mechanism of Action	Calcium Channel Antagonists Cytochrome P450 3A4 Inhibitors

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:	RX	Dosage:	TABLET;ORAL			Strength	30MG
Approval Date:	Nov 5, 1982	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	60MG
Approval Date:	Nov 5, 1982	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	90MG
Approval Date:	Dec 8, 1986	TE:	AB	RLD:	Yes

Expired US Patents for NDA 018602

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	CARDIZEM	diltiazem hydrochloride	TABLET;ORAL	018602-004	Dec 8, 1986	⤷ Get Started Free	⤷ Get Started Free
Bausch	CARDIZEM	diltiazem hydrochloride	TABLET;ORAL	018602-001	Nov 5, 1982	⤷ Get Started Free	⤷ Get Started Free
Bausch	CARDIZEM	diltiazem hydrochloride	TABLET;ORAL	018602-004	Dec 8, 1986	⤷ Get Started Free	⤷ Get Started Free
Bausch	CARDIZEM	diltiazem hydrochloride	TABLET;ORAL	018602-004	Dec 8, 1986	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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