BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Healthtrust
AstraZeneca
McKesson
Cantor Fitzgerald
Cipla
Novartis
McKinsey
Julphar
Baxter

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078115

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NDA 078115 describes CARBAMAZEPINE, which is a drug marketed by Apotex Inc, Mylan Ireland Ltd, Taro, Teva Pharms, Wockhardt, Jubilant Cadista, Taro Pharm Inds, Torrent Pharms, Actavis Elizabeth, Inwood Labs, Pliva, Usl Pharma, and Warner Chilcott, and is included in eighteen NDAs. It is available from thirty 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 078115
Tradename:CARBAMAZEPINE
Applicant:Taro
Ingredient:carbamazepine
Patents:0
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 51672-4123-6 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4123-6)
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)

Profile for product number 001

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

Profile for product number 002

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

Profile 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 leading biopharmaceutical companies globally:

US Department of Justice
US Army
Johnson and Johnson
Julphar
Accenture
Mallinckrodt
McKesson
Baxter
Dow

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