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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Argus Health
Johnson and Johnson
Julphar
Chinese Patent Office
Merck
Fuji
McKesson
Queensland Health

Generated: June 23, 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:

Merck
Dow
Mallinckrodt
Baxter
Johnson and Johnson
McKinsey
Fuji
Deloitte
Chubb

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