Details for New Drug Application (NDA): 211711

NDA 211711 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 211711

Tradename:	CLOBAZAM
Applicant:	Micro Labs
Ingredient:	clobazam
Patents:	0

Pharmacology for NDA: 211711

Mechanism of Action

Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inducers

Suppliers and Packaging for NDA: 211711

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLOBAZAM	clobazam	TABLET;ORAL	211711	ANDA	Micro Labs Limited	42571-315	42571-315-01	100 TABLET in 1 BOTTLE (42571-315-01)
CLOBAZAM	clobazam	TABLET;ORAL	211711	ANDA	Micro Labs Limited	42571-315	42571-315-05	500 TABLET in 1 BOTTLE (42571-315-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Jan 30, 2019	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Jan 30, 2019	TE:	AB	RLD:	No

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