Details for New Drug Application (NDA): 021875

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NDA 021875 describes NUVIGIL, which is a drug marketed by Cephalon and is included in one NDA. It is available from seven suppliers. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the NUVIGIL profile page.

The generic ingredient in NUVIGIL is armodafinil. There are twelve drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the armodafinil profile page.

Summary for 021875

Tradename:	NUVIGIL
Applicant:	Cephalon
Ingredient:	armodafinil
Patents:	2

Suppliers and Packaging for NDA: 021875

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NUVIGIL	armodafinil	TABLET;ORAL	021875	NDA AUTHORIZED GENERIC	Teva Pharmaceuticals USA, Inc.	0093-3090	0093-3090-56	30 TABLET in 1 BOTTLE (0093-3090-56)
NUVIGIL	armodafinil	TABLET;ORAL	021875	NDA AUTHORIZED GENERIC	Teva Pharmaceuticals USA, Inc.	0093-3092	0093-3092-56	30 TABLET in 1 BOTTLE (0093-3092-56)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG
Approval Date:	Jun 15, 2007	TE:	AB	RLD:	Yes
Patent:	7,132,570*PED	Patent Expiration:	Jun 18, 2024	Product Flag?		Substance Flag?		Delist Request?
Patent:	7,297,346*PED	Patent Expiration:	May 29, 2024	Product Flag?		Substance Flag?		Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Mar 26, 2009	TE:		RLD:	Yes
Patent:	7,132,570*PED	Patent Expiration:	Jun 18, 2024	Product Flag?		Substance Flag?		Delist Request?

Expired US Patents for NDA 021875

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cephalon	NUVIGIL	armodafinil	TABLET;ORAL	021875-002	Mar 26, 2009	7,132,570*PED	⤷ Subscribe
Cephalon	NUVIGIL	armodafinil	TABLET;ORAL	021875-003	Jun 15, 2007	4,927,855*PED	⤷ Subscribe
Cephalon	NUVIGIL	armodafinil	TABLET;ORAL	021875-004	Jun 15, 2007	4,927,855*PED	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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