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Serving leading biopharmaceutical companies globally:

Cerilliant
Express Scripts
Colorcon
Julphar
Cantor Fitzgerald
Dow
Fuji
Deloitte
Cipla
Chubb

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077614

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NDA 077614 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 077614
Tradename:CARVEDILOL
Applicant:Zydus Pharms Usa Inc
Ingredient:carvedilol
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 077614
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARVEDILOL carvedilol TABLET;ORAL 077614 ANDA Unit Dose Services 50436-2608 50436-2608-4 180 TABLET, FILM COATED in 1 BOTTLE (50436-2608-4)
CARVEDILOL carvedilol TABLET;ORAL 077614 ANDA Unit Dose Services 50436-2608 50436-2608-2 60 TABLET, FILM COATED in 1 BOTTLE (50436-2608-2)

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Sep 5, 2007TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Boehringer Ingelheim
AstraZeneca
Express Scripts
Merck
Novartis
Colorcon
Fish and Richardson
Medtronic

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