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Serving 500+ biopharmaceutical companies globally:

Merck
McKesson
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Citi
Colorcon
McKinsey
Harvard Business School
Moodys

Generated: July 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078115

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NDA 078115 describes CARBAMAZEPINE, which is a drug marketed by Usl Pharma, Taro, Torrent Pharms, Wockhardt, Warner Chilcott, Inwood Labs, Jubilant Cadista, Apotex Inc, Pliva, Taro Pharm Inds, Teva Pharms, Actavis Elizabeth, and Mylan Ireland Ltd, and is included in eighteen NDAs. It is available from twenty-eight suppliers. Additional details are available on the CARBAMAZEPINE profile page.

The generic ingredient in CARBAMAZEPINE is carbamazepine. There are twenty-seven drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the carbamazepine profile page.

Summary for NDA: 078115

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Anticonvulsants
Bipolar Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 078115

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARBAMAZEPINE
carbamazepine
TABLET, EXTENDED RELEASE;ORAL 078115 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-4123 51672-4123-1 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4123-1)
CARBAMAZEPINE
carbamazepine
TABLET, EXTENDED RELEASE;ORAL 078115 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-4123 51672-4123-3 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4123-3)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength100MG
Approval Date:Mar 31, 2009TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength200MG
Approval Date:Mar 31, 2009TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength400MG
Approval Date:Mar 31, 2009TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Covington
Boehringer Ingelheim
Dow
US Department of Justice
Mallinckrodt
Novartis
Merck
US Army
Accenture
QuintilesIMS

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