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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 212714


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NDA 212714 describes CLOBAZAM, which is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Amneal, Aurobindo Pharma Ltd, Bionpharma, Chartwell Molecular, Hetero Labs Ltd Iii, Hikma, Lupin Ltd, Pharmobedient, Taro, Teva Pharms Usa, Upsher Smith Labs, Vistapharm Llc, Amneal Pharms Co, Apotex, Chartwell Rx, Micro Labs, MSN, Novitium Pharma, Piramal, and Zydus Pharms, and is included in thirty-one NDAs. It is available from fifteen suppliers. Additional details are available on the CLOBAZAM profile page.

The generic ingredient in CLOBAZAM is clobazam. There are ten drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the clobazam profile page.
Summary for 212714
Tradename:CLOBAZAM
Applicant:Alkem Labs Ltd
Ingredient:clobazam
Patents:0
Pharmacology for NDA: 212714
Mechanism of ActionCytochrome P450 2D6 Inhibitors
Cytochrome P450 3A4 Inducers
Suppliers and Packaging for NDA: 212714
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOBAZAM clobazam TABLET;ORAL 212714 ANDA Ascend Laboratories, LLC 67877-664 67877-664-01 1 BOTTLE in 1 CARTON (67877-664-01) / 100 TABLET in 1 BOTTLE
CLOBAZAM clobazam TABLET;ORAL 212714 ANDA Ascend Laboratories, LLC 67877-664 67877-664-05 500 TABLET in 1 BOTTLE (67877-664-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Sep 6, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Sep 6, 2019TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Dec 21, 2020TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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