Details for New Drug Application (NDA): 202067

NDA 202067 describes ONFI, which is a drug marketed by Lundbeck Pharms Llc and is included in two NDAs. It is available from one supplier. Additional details are available on the ONFI profile page.

The generic ingredient in ONFI 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 202067

Tradename:	ONFI
Applicant:	Lundbeck Pharms Llc
Ingredient:	clobazam
Patents:	0

Pharmacology for NDA: 202067

Mechanism of Action

Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inducers

Suppliers and Packaging for NDA: 202067

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ONFI	clobazam	TABLET;ORAL	202067	NDA	Lundbeck Pharmaceuticals LLC	67386-314	67386-314-01	1 BOTTLE in 1 CARTON (67386-314-01) / 100 TABLET in 1 BOTTLE
ONFI	clobazam	TABLET;ORAL	202067	NDA	Lundbeck Pharmaceuticals LLC	67386-315	67386-315-01	1 BOTTLE in 1 CARTON (67386-315-01) / 100 TABLET in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Oct 21, 2011	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Oct 21, 2011	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Oct 21, 2011	TE:	AB	RLD:	Yes

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