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Serving leading biopharmaceutical companies globally:

Argus Health
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Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075948

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NDA 075948 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 twenty-nine 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-one suppliers are listed for this compound. Additional details are available on the carbamazepine profile page.

Summary for 075948

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

Medical Subject Heading (MeSH) Categories for 075948

Suppliers and Packaging for NDA: 075948

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARBAMAZEPINE carbamazepine TABLET;ORAL 075948 ANDA Aphena Pharma Solutions - Tennessee, LLC 43353-953 43353-953-53 60 TABLET in 1 BOTTLE (43353-953-53)
CARBAMAZEPINE carbamazepine TABLET;ORAL 075948 ANDA Aphena Pharma Solutions - Tennessee, LLC 43353-953 43353-953-80 180 TABLET in 1 BOTTLE (43353-953-80)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Feb 27, 2002TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

McKinsey
Covington
Medtronic
Chubb
Farmers Insurance
Julphar
Express Scripts
Teva
US Department of Justice
Colorcon

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