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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201106

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NDA 201106 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 201106

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

Medical Subject Heading (MeSH) Categories for 201106

Suppliers and Packaging for NDA: 201106

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARBAMAZEPINE carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 201106 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-4149 51672-4149-1 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (51672-4149-1)
CARBAMAZEPINE carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 201106 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-4149 51672-4149-6 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (51672-4149-6)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength100MG
Approval Date:Jun 21, 2013TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength200MG
Approval Date:Jun 21, 2013TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength300MG
Approval Date:Jun 21, 2013TE:ABRLD:No


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