Details for New Drug Application (NDA): 019471

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NDA 019471 describes CARDIZEM SR, which is a drug marketed by Biovail and is included in one NDA. Additional details are available on the CARDIZEM SR profile page.

The generic ingredient in CARDIZEM SR 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 019471

Tradename:	CARDIZEM SR
Applicant:	Biovail
Ingredient:	diltiazem hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jan 23, 1989	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	90MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jan 23, 1989	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	120MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jan 23, 1989	TE:		RLD:	Yes

Expired US Patents for NDA 019471

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Biovail	CARDIZEM SR	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	019471-001	Jan 23, 1989	4,721,619	⤷ Subscribe
Biovail	CARDIZEM SR	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	019471-004	Jan 23, 1989	4,721,619	⤷ Subscribe
Biovail	CARDIZEM SR	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	019471-003	Jan 23, 1989	4,721,619	⤷ Subscribe
Biovail	CARDIZEM SR	diltiazem hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	019471-002	Jan 23, 1989	4,721,619	⤷ Subscribe
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