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Federal Trade Commission
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Fuji
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McKesson
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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078240

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NDA 078240 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-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. Five suppliers are listed for this compound. Additional details are available on the carvedilol phosphate profile page.

Summary for 078240

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength3.125MG
Approval Date:Oct 30, 2007TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength6.25MG
Approval Date:Oct 30, 2007TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength12.5MG
Approval Date:Oct 30, 2007TE:RLD:No


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Serving leading biopharmaceutical companies globally:

Colorcon
Covington
McKinsey
Teva
Healthtrust
Deloitte
Baxter
Cipla
Moodys
Farmers Insurance

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