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Last Updated: April 22, 2025

Details for New Drug Application (NDA): 210569

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NDA 210569 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, Norvium Bioscience, Taro, Teva Pharms Usa, Upsher Smith Labs, Vistapharm Llc, Amneal Pharms Co, Anda Repository, Apotex, Esjay Pharma, Micro Labs, MSN, Piramal, and Zydus Pharms, and is included in thirty-one NDAs. It is available from nineteen 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. Twenty-one suppliers are listed for this compound. Additional details are available on the clobazam profile page.

Summary for 210569

Tradename:	CLOBAZAM
Applicant:	Upsher Smith Labs
Ingredient:	clobazam
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SUSPENSION;ORAL			Strength	2.5MG/ML
Approval Date:	Oct 22, 2018	TE:		RLD:	No

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