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Serving leading biopharmaceutical companies globally:

US Army
Cantor Fitzgerald
QuintilesIMS
Mallinckrodt
AstraZeneca
Federal Trade Commission
Queensland Health
McKinsey
Chubb
Deloitte

Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078227

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NDA 078227 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 078227
Tradename:CARVEDILOL
Applicant:Sandoz
Ingredient:carvedilol
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 078227
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARVEDILOL carvedilol TABLET;ORAL 078227 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-6583 0615-6583-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-6583-39)
CARVEDILOL carvedilol TABLET;ORAL 078227 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-6583 0615-6583-30 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-6583-30) > 5 TABLET, FILM COATED in 1 BLISTER PACK

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 leading biopharmaceutical companies globally:

Argus Health
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Cerilliant
Cipla
Healthtrust
Novartis
QuintilesIMS
Teva
AstraZeneca

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