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Generated: March 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075712

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NDA 075712 describes CARBAMAZEPINE, which is a drug marketed by Apotex Inc, Mylan Ireland Ltd, Taro, Teva Pharms, Wockhardt Bio Ag, 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-one suppliers are listed for this compound. Additional details are available on the carbamazepine profile page.
Summary for 075712
Applicant:Torrent Pharms
Therapeutic Class:Anticonvulsants
Bipolar Agents
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 075712
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARBAMAZEPINE carbamazepine TABLET, CHEWABLE;ORAL 075712 ANDA Major Pharmaceuticals 0904-3854 N 0904-3854-80
CARBAMAZEPINE carbamazepine TABLET, CHEWABLE;ORAL 075712 ANDA Major Pharmaceuticals 0904-3854 N 0904-3854-61

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrength100MG
Approval Date:Jul 5, 2001TE:ABRLD:No

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