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Serving leading biopharmaceutical companies globally:

Medtronic
US Army
Fish and Richardson
Johnson and Johnson
Julphar
Fuji
Cerilliant
Merck
McKesson
Boehringer Ingelheim

Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078332

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NDA 078332 describes CARVEDILOL, which is a drug marketed by Apotex Inc, Aurobindo Pharma, Beximco Usa, Cipla Ltd, Dr Reddys Labs Ltd, Glenmark Generics, Hikma, Lupin, Mylan, Pliva Hrvatska Doo, Sandoz, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Taro, Teva, Wockhardt Ltd, Zydus Pharms Usa Inc, and Sun Pharm Industries, and is included in eighteen NDAs. It is available from fifty-three suppliers. Additional details are available on the CARVEDILOL profile page.

The generic ingredient in CARVEDILOL is carvedilol phosphate. There are thirty-six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the carvedilol phosphate profile page.
Summary for 078332
Tradename:CARVEDILOL
Applicant:Aurobindo Pharma
Ingredient:carvedilol
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 078332
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARVEDILOL carvedilol TABLET;ORAL 078332 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7944 N 0615-7944-30
CARVEDILOL carvedilol TABLET;ORAL 078332 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7944 N 0615-7944-39

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength3.125MG
Approval Date:Sep 5, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength6.25MG
Approval Date:Sep 5, 2007TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG
Approval Date:Sep 5, 2007TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
US Department of Justice
Harvard Business School
Cantor Fitzgerald
Dow
Daiichi Sankyo
Healthtrust
Argus Health
Teva

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