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Serving 500+ biopharmaceutical companies globally:

Chinese Patent Office
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Generated: June 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078227

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NDA 078227 describes CARVEDILOL, which is a drug marketed by Zydus Pharms Usa Inc, Mylan, Lupin, Sandoz, Aurobindo Pharma, Pliva Hrvatska Doo, Sun Pharm Inds Inc, Dr Reddys Labs Ltd, Glenmark Generics, Apotex Inc, Teva, Cipla Ltd, Taro, Beximco Usa, Wockhardt Ltd, Hikma, and Sun Pharm Inds Ltd, and is included in seventeen NDAs. It is available from fifty-one suppliers. Additional details are available on the CARVEDILOL profile page.

The generic ingredient in CARVEDILOL is carvedilol. There are thirty-six drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the carvedilol profile page.

Summary for NDA: 078227

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
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 0615-6583-30 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-6583-30) > 5 TABLET, FILM COATED in 1 BLISTER PACK
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)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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Serving 500+ biopharmaceutical companies globally:

Moodys
UBS
QuintilesIMS
McKinsey
Chubb
Express Scripts
Teva
Boehringer Ingelheim
Daiichi Sankyo
US Army

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