Details for New Drug Application (NDA): 209718

NDA 209718 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, Amneal Pharms Co, Anda Repository, Apotex, Breckenridge, Micro Labs, MSN, Piramal, and Zydus Pharms, and is included in thirty-one NDAs. It is available from twenty-one 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-three suppliers are listed for this compound. Additional details are available on the clobazam profile page.

Summary for 209718

Tradename:	CLOBAZAM
Applicant:	Amneal Pharms Co
Ingredient:	clobazam
Patents:	0

Pharmacology for NDA: 209718

Mechanism of Action

Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inducers

Suppliers and Packaging for NDA: 209718

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLOBAZAM	clobazam	TABLET;ORAL	209718	ANDA	American Health Packaging	60687-423	60687-423-21	30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-423-21) / 1 TABLET in 1 BLISTER PACK (60687-423-11)
CLOBAZAM	clobazam	TABLET;ORAL	209718	ANDA	Amneal Pharmaceuticals NY LLC	69238-1305	69238-1305-1	100 TABLET in 1 BOTTLE (69238-1305-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Oct 22, 2018	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Oct 22, 2018	TE:	AB	RLD:	No

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