Details for New Drug Application (NDA): 213404

NDA 213404 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, Apotex, Breckenridge, Celltrion, Micro Labs, MSN, Piramal Hlthcare Uk, 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 213404

Tradename:	CLOBAZAM
Applicant:	Msn
Ingredient:	clobazam
Patents:	0

Pharmacology for NDA: 213404

Mechanism of Action

Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inducers

Suppliers and Packaging for NDA: 213404

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLOBAZAM	clobazam	TABLET;ORAL	213404	ANDA	MSN LABORATORIES PRIVATE LIMITED	69539-153	69539-153-91	1 BOTTLE in 1 CARTON (69539-153-91) / 100 TABLET in 1 BOTTLE
CLOBAZAM	clobazam	TABLET;ORAL	213404	ANDA	MSN LABORATORIES PRIVATE LIMITED	69539-153	69539-153-99	1 BOTTLE in 1 CARTON (69539-153-99) / 100 TABLET in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	May 11, 2021	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	May 11, 2021	TE:	AB	RLD:	No

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