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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 214404

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NDA 214404 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 214404

Tradename:	CLOBAZAM
Applicant:	Aurobindo Pharma Ltd
Ingredient:	clobazam
Patents:	0

Pharmacology for NDA: 214404

Mechanism of Action	Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inducers

Suppliers and Packaging for NDA: 214404

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLOBAZAM	clobazam	SUSPENSION;ORAL	214404	ANDA	Aurobindo Pharma Limited	59651-401	59651-401-12	1 BOTTLE in 1 CARTON (59651-401-12) / 120 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	2.5MG/ML
Approval Date:	Mar 24, 2022	TE:	AB	RLD:	No

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