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-three 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

Pharmacology for NDA: 021392

Mechanism of Action	Calcium 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:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	120MG
Approval Date:	Feb 6, 2003	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	180MG
Approval Date:	Feb 6, 2003	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	240MG
Approval Date:	Feb 6, 2003	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021392

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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	⤷ Sign Up	⤷ Sign Up
Bausch	CARDIZEM LA	diltiazem hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021392-004	Feb 6, 2003	⤷ Sign Up	⤷ Sign Up
Bausch	CARDIZEM LA	diltiazem hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021392-003	Feb 6, 2003	⤷ Sign Up	⤷ Sign Up
Bausch	CARDIZEM LA	diltiazem hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021392-001	Feb 6, 2003	⤷ Sign Up	⤷ Sign Up
Bausch	CARDIZEM LA	diltiazem hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021392-005	Feb 6, 2003	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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