Last Updated: November 8, 2026

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, Pharmobedient, Taro, Teva Pharms Usa, Upsher Smith Labs, Vistapharm Llc, Amneal Pharms Co, Apotex, Chartwell Rx, Micro Labs, MSN, Novitium Pharma, Pharmazone, and Zydus Pharms, and is included in thirty-one NDAs. It is available from sixteen suppliers. Additional details are available on the CLOBAZAM profile page.

The generic ingredient in CLOBAZAM is clobazam. There is one drug master file entry for this compound. Eighteen 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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