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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 216235


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NDA 216235 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, Apotex, Cspc Ouyi, Riconpharma Llc, Sciecure Pharma Inc, Umedica, Unique Pharm, Zhejiang Jiuzhou, Zydus Pharms, Actavis Elizabeth, Bionpharma, Inwood Labs, Pliva, Rk Pharma, Unichem, Usl Pharma, and Warner Chilcott, and is included in thirty-four NDAs. It is available from thirty-eight 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-six suppliers are listed for this compound. Additional details are available on the carbamazepine profile page.
Summary for 216235
Tradename:CARBAMAZEPINE
Applicant:Sciecure Pharma Inc
Ingredient:carbamazepine
Patents:0
Suppliers and Packaging for NDA: 216235
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARBAMAZEPINE carbamazepine TABLET, EXTENDED RELEASE;ORAL 216235 ANDA Epic Pharma, LLC 42806-274 42806-274-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-274-01)
CARBAMAZEPINE carbamazepine TABLET, EXTENDED RELEASE;ORAL 216235 ANDA Epic Pharma, LLC 42806-275 42806-275-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42806-275-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength100MG
Approval Date:Mar 2, 2023TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength200MG
Approval Date:Mar 2, 2023TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength400MG
Approval Date:Mar 2, 2023TE:ABRLD:No

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