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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
UBS
Accenture
Queensland Health
Deloitte
AstraZeneca
Dow
Moodys
Medtronic

Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040298

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NDA 040298 describes PHENYTEK, which is a drug marketed by Mylan and is included in one NDA. It is available from seven suppliers. Additional details are available on the PHENYTEK profile page.

The generic ingredient in PHENYTEK is phenytoin sodium. There are twenty drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the phenytoin sodium profile page.
Summary for 040298
Tradename:PHENYTEK
Applicant:Mylan
Ingredient:phenytoin sodium
Patents:0
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 040298
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EXTENDED PHENYTOIN SODIUM phenytoin sodium CAPSULE;ORAL 040298 ANDA Mylan Pharmaceuticals Inc. 0378-1560 N 0378-1560-01
EXTENDED PHENYTOIN SODIUM phenytoin sodium CAPSULE;ORAL 040298 ANDA Mylan Pharmaceuticals Inc. 0378-1560 N 0378-1560-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG EXTENDED
Approval Date:Dec 28, 1998TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG EXTENDED
Approval Date:Dec 6, 2001TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength300MG EXTENDED
Approval Date:Dec 6, 2001TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Argus Health
Chubb
UBS
Moodys
Teva
Queensland Health
Johnson and Johnson
Merck

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