Details for New Drug Application (NDA): 209796

NDA 209796 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 209796

Tradename:	CLOBAZAM
Applicant:	Hetero Labs Ltd Iii
Ingredient:	clobazam
Patents:	0

Pharmacology for NDA: 209796

Mechanism of Action

Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inducers

Suppliers and Packaging for NDA: 209796

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLOBAZAM	clobazam	SUSPENSION;ORAL	209796	ANDA	NorthStar RxLLC	16714-087	16714-087-01	1 BOTTLE, GLASS in 1 CARTON (16714-087-01) / 120 mL in 1 BOTTLE, GLASS
CLOBAZAM	clobazam	SUSPENSION;ORAL	209796	ANDA	Camber Pharmaceuticals, Inc.	31722-641	31722-641-12	1 BOTTLE, GLASS in 1 CARTON (31722-641-12) / 120 mL in 1 BOTTLE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	2.5MG/ML
Approval Date:	Feb 24, 2020	TE:	AB	RLD:	No

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