Details for New Drug Application (NDA): 020717

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NDA 020717 describes PROVIGIL, which is a drug marketed by Cephalon and is included in one NDA. It is available from three suppliers. There is one patent protecting this drug. Additional details are available on the PROVIGIL profile page.

The generic ingredient in PROVIGIL is modafinil. There are twenty-six drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the modafinil profile page.

Summary for 020717

Tradename:	PROVIGIL
Applicant:	Cephalon
Ingredient:	modafinil
Patents:	1
Formulation / Manufacturing:	see details

Pharmacology for NDA: 020717

Physiological Effect	Central Nervous System Stimulation Increased Sympathetic Activity

Suppliers and Packaging for NDA: 020717

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PROVIGIL	modafinil	TABLET;ORAL	020717	NDA AUTHORIZED GENERIC	Aphena Pharma Solutions - Tennessee, LLC	43353-925	43353-925-30	30 TABLET in 1 BOTTLE, PLASTIC (43353-925-30)
PROVIGIL	modafinil	TABLET;ORAL	020717	NDA AUTHORIZED GENERIC	Aphena Pharma Solutions - Tennessee, LLC	43353-925	43353-925-53	60 TABLET in 1 BOTTLE, PLASTIC (43353-925-53)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Dec 24, 1998	TE:	AB	RLD:	Yes
Patent:	See Plans and Pricing	Patent Expiration:	May 29, 2024	Product Flag?		Substance Flag?		Delist Request?	Y

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Dec 24, 1998	TE:	AB	RLD:	Yes
Patent:	See Plans and Pricing	Patent Expiration:	May 29, 2024	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 020717

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cephalon	PROVIGIL	modafinil	TABLET;ORAL	020717-001	Dec 24, 1998	See Plans and Pricing	See Plans and Pricing
Cephalon	PROVIGIL	modafinil	TABLET;ORAL	020717-002	Dec 24, 1998	See Plans and Pricing	See Plans and Pricing
Cephalon	PROVIGIL	modafinil	TABLET;ORAL	020717-001	Dec 24, 1998	See Plans and Pricing	See Plans and Pricing
Cephalon	PROVIGIL	modafinil	TABLET;ORAL	020717-002	Dec 24, 1998	See Plans and Pricing	See Plans and Pricing
Cephalon	PROVIGIL	modafinil	TABLET;ORAL	020717-001	Dec 24, 1998	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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