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Generated: November 20, 2018

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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 nine 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. Thirty-one 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
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 Rebel Distributors Corp 21695-234 21695-234-15 15 TABLET in 1 BOTTLE (21695-234-15)
PROVIGIL modafinil TABLET;ORAL 020717 NDA Rebel Distributors Corp 21695-234 21695-234-30 30 TABLET in 1 BOTTLE (21695-234-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Dec 24, 1998TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:May 29, 2024Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Dec 24, 1998TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:May 29, 2024Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 020717

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cephalon PROVIGIL modafinil TABLET;ORAL 020717-001 Dec 24, 1998 ➤ Sign Up ➤ Sign Up
Cephalon PROVIGIL modafinil TABLET;ORAL 020717-001 Dec 24, 1998 ➤ Sign Up ➤ Sign Up
Cephalon PROVIGIL modafinil TABLET;ORAL 020717-002 Dec 24, 1998 ➤ Sign Up ➤ Sign Up
Cephalon PROVIGIL modafinil TABLET;ORAL 020717-002 Dec 24, 1998 ➤ Sign Up ➤ Sign Up
Cephalon PROVIGIL modafinil TABLET;ORAL 020717-002 Dec 24, 1998 ➤ Sign Up ➤ Sign Up
Cephalon PROVIGIL modafinil TABLET;ORAL 020717-002 Dec 24, 1998 ➤ Sign Up ➤ Sign Up
Cephalon PROVIGIL modafinil TABLET;ORAL 020717-001 Dec 24, 1998 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
McKinsey
Dow
Cerilliant
Argus Health
Colorcon
UBS
Fuji
Deloitte

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