Details for New Drug Application (NDA): 018602

✉ Email this page to a colleague

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. Fifty-five 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

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

Subscribe to access the full database, or Subscribe
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	CARDIZEM	diltiazem hydrochloride	TABLET;ORAL	018602-004	Dec 8, 1986	⤷ Subscribe	⤷ Subscribe
Bausch	CARDIZEM	diltiazem hydrochloride	TABLET;ORAL	018602-001	Nov 5, 1982	⤷ Subscribe	⤷ Subscribe
Bausch	CARDIZEM	diltiazem hydrochloride	TABLET;ORAL	018602-004	Dec 8, 1986	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.