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Last Updated: April 18, 2024

Details for New Drug Application (NDA): 020062

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NDA 020062 describes CARDIZEM CD, which is a drug marketed by Bausch and is included in one NDA. It is available from three suppliers. Additional details are available on the CARDIZEM CD profile page.

The generic ingredient in CARDIZEM CD is diltiazem hydrochloride. There are twenty-six drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.

Summary for 020062

Tradename:	CARDIZEM CD
Applicant:	Bausch
Ingredient:	diltiazem hydrochloride
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 020062

Mechanism of Action	Calcium Channel Antagonists Cytochrome P450 3A4 Inhibitors

Suppliers and Packaging for NDA: 020062

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CARDIZEM CD	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020062	NDA	Bausch Health US LLC	0187-0795	0187-0795-30	30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0187-0795-30)
CARDIZEM CD	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020062	NDA	Bausch Health US LLC	0187-0795	0187-0795-42	90 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0187-0795-42)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	120MG
Approval Date:	Aug 10, 1992	TE:	AB3	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	180MG
Approval Date:	Dec 27, 1991	TE:	AB3	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	240MG
Approval Date:	Dec 27, 1991	TE:	AB3	RLD:	Yes

Expired US Patents for NDA 020062

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	CARDIZEM CD	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020062-001	Aug 10, 1992	⤷ Try a Trial	⤷ Try a Trial
Bausch	CARDIZEM CD	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020062-001	Aug 10, 1992	⤷ Try a Trial	⤷ Try a Trial
Bausch	CARDIZEM CD	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020062-003	Dec 27, 1991	⤷ Try a Trial	⤷ Try a Trial
Bausch	CARDIZEM CD	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020062-001	Aug 10, 1992	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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