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Last Updated: December 31, 2025

Details for New Drug Application (NDA): 210746

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NDA 210746 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 210746

Tradename:	CLOBAZAM
Applicant:	Vistapharm Llc
Ingredient:	clobazam
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SUSPENSION;ORAL			Strength	2.5MG/ML
Approval Date:	Jul 10, 2019	TE:		RLD:	No

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