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Serving hundreds of leading biopharmaceutical companies globally:

UBS
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Covington
US Army
Baxter
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Chubb
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Cipla

Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078251

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NDA 078251 describes CARVEDILOL, which is a drug marketed by Apotex Inc, Aurobindo Pharma, Beximco Usa, Chartwell Molecular, 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, Impax Labs Inc, and Sun Pharm Industries, and is included in nineteen NDAs. It is available from fifty-two 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. Six suppliers are listed for this compound. Additional details are available on the carvedilol phosphate profile page.
Summary for 078251
Tradename:CARVEDILOL
Applicant:Glenmark Generics
Ingredient:carvedilol
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 078251
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARVEDILOL carvedilol TABLET;ORAL 078251 ANDA Aidarex Pharmaceuticals LLC 33261-537 N 33261-537-30
CARVEDILOL carvedilol TABLET;ORAL 078251 ANDA Aidarex Pharmaceuticals LLC 33261-537 N 33261-537-90

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:

Medtronic
Teva
Cipla
Cerilliant
Citi
Mallinckrodt
Colorcon
Federal Trade Commission
Julphar

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