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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 211623


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NDA 211623 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 211623
Tradename:CARBAMAZEPINE
Applicant:Unique Pharm
Ingredient:carbamazepine
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 211623
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARBAMAZEPINE carbamazepine TABLET, EXTENDED RELEASE;ORAL 211623 ANDA Rising Pharma Holdings, Inc. 16571-680 16571-680-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-680-01)
CARBAMAZEPINE carbamazepine TABLET, EXTENDED RELEASE;ORAL 211623 ANDA Rising Pharma Holdings, Inc. 16571-681 16571-681-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16571-681-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength100MG
Approval Date:Apr 24, 2020TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength200MG
Approval Date:Apr 24, 2020TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength400MG
Approval Date:Apr 24, 2020TE:ABRLD:No

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