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Generated: September 23, 2018

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Details for New Drug Application (NDA): 078986

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NDA 078986 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-one 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 078986
Tradename:CARBAMAZEPINE
Applicant:Apotex Inc
Ingredient:carbamazepine
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 078986
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARBAMAZEPINE carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 078986 ANDA Apotex Corp. 60505-2805 60505-2805-0 10 BLISTER PACK in 1 CARTON (60505-2805-0) > 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK
CARBAMAZEPINE carbamazepine CAPSULE, EXTENDED RELEASE;ORAL 078986 ANDA Apotex Corp. 60505-2805 60505-2805-3 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (60505-2805-3)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength100MG
Approval Date:Nov 25, 2011TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength200MG
Approval Date:Nov 25, 2011TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength300MG
Approval Date:Nov 25, 2011TE:ABRLD:No

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