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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 twelve 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-eight suppliers are listed for this compound. There are eight tentative approvals for this compound. Additional details are available on the modafinil profile page.

Summary for NDA: 020717

Tradename:
PROVIGIL
Applicant:
Cephalon
Ingredient:
modafinil
Patents:1
Therapeutic Class:Central Nervous System Agents
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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Dec 24, 1998TE:ABRLD:No
Patent:7,297,346*PEDPatent Expiration:May 29, 2024Product Flag?Substance Flag?Delist Request?Y

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Dec 24, 1998TE:ABRLD:Yes
Patent:7,297,346*PEDPatent Expiration:May 29, 2024Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 020717

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cephalon
PROVIGIL
modafinil
TABLET;ORAL020717-002Dec 24, 19985,618,845► subscribe
Cephalon
PROVIGIL
modafinil
TABLET;ORAL020717-002Dec 24, 1998RE37516*PED► subscribe
Cephalon
PROVIGIL
modafinil
TABLET;ORAL020717-001Dec 24, 19984,177,290► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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