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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 075687


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NDA 075687 describes CARBAMAZEPINE, which is a drug marketed by Apotex Inc, Nostrum Labs Inc, Taro, Teva Pharms, Chartwell Rx, Novitium Pharma, Jubilant Cadista, Taro Pharm Inds, Torrent Pharms, Ajanta Pharma Ltd, Amneal Pharms, Anbison Lab, Cspc Ouyi, Riconpharma Llc, Sciecure Pharma Inc, Umedica, Unique Pharm, Zhejiang Jiuzhou, Zydus Pharms, Actavis Elizabeth, Inwood Labs, Pliva, Rk Pharma, Unichem, Usl Pharma, and Warner Chilcott, and is included in thirty-two NDAs. It is available from thirty-seven 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-five suppliers are listed for this compound. Additional details are available on the carbamazepine profile page.
Summary for 075687
Tradename:CARBAMAZEPINE
Applicant:Taro Pharm Inds
Ingredient:carbamazepine
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 075687
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARBAMAZEPINE carbamazepine TABLET, CHEWABLE;ORAL 075687 ANDA NCS HealthCare of KY, LLC dba Vangard Labs 0615-8125 0615-8125-39 30 TABLET, CHEWABLE in 1 BLISTER PACK (0615-8125-39)
CARBAMAZEPINE carbamazepine TABLET, CHEWABLE;ORAL 075687 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-4041 51672-4041-0 10 BLISTER PACK in 1 CARTON (51672-4041-0) / 10 TABLET, CHEWABLE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrength100MG
Approval Date:Oct 24, 2000TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrength200MG
Approval Date:Jul 29, 2002TE:RLD:No

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