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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Boehringer Ingelheim
Fish and Richardson
Colorcon
Mallinckrodt
Citi
Express Scripts
Medtronic
Dow

Generated: May 23, 2018

DrugPatentWatch Database Preview

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-seven 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
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Profile 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EXTENDED RELEASE;ORALStrength60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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

Profile 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EXTENDED RELEASE;ORALStrength90MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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

Profile 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EXTENDED RELEASE;ORALStrength120MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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 US Patents for NDA 019471

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Biovail CARDIZEM SR diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 019471-003 Jan 23, 1989 ➤ Try a Free Trial ➤ Try a Free Trial
Biovail CARDIZEM SR diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 019471-001 Jan 23, 1989 ➤ Try a Free Trial ➤ Try a Free Trial
Biovail CARDIZEM SR diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 019471-004 Jan 23, 1989 ➤ Try a Free Trial ➤ Try a Free Trial
Biovail CARDIZEM SR diltiazem hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 019471-002 Jan 23, 1989 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
McKesson
Chinese Patent Office
Cipla
QuintilesIMS
Queensland Health
Merck
US Department of Justice
UBS

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