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Generated: May 24, 2017

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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. Forty-five suppliers are listed for this compound. Additional details are available on the diltiazem hydrochloride profile page.

Summary for NDA: 019471

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrength60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jan 23, 1989TE:RLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrength90MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jan 23, 1989TE:RLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrength120MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jan 23, 1989TE:RLD:Yes

Expired Orange Book Patents for NDA: 019471

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Biovail
CARDIZEM SR
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL019471-003Jan 23, 19894,721,619► Subscribe
Biovail
CARDIZEM SR
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL019471-001Jan 23, 19894,721,619► Subscribe
Biovail
CARDIZEM SR
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL019471-004Jan 23, 19894,721,619► Subscribe
Biovail
CARDIZEM SR
diltiazem hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL019471-002Jan 23, 19894,721,619► Subscribe
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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 verifification 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.

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