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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Baxter
Moodys
Cantor Fitzgerald
McKinsey
Colorcon
Chubb
Cerilliant
Chinese Patent Office
Mallinckrodt

Generated: January 20, 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 nine suppliers. Additional details are available on the PHENYTEK profile page.

The generic ingredient in PHENYTEK is phenytoin sodium. There are nineteen drug master file entries for this compound. Forty-two 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 0378-1560-10 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1560-10)
EXTENDED PHENYTOIN SODIUM phenytoin sodium CAPSULE;ORAL 040298 ANDA Mylan Pharmaceuticals Inc. 0378-1560 0378-1560-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1560-01)

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 leading biopharmaceutical companies globally:

Chinese Patent Office
Daiichi Sankyo
Queensland Health
Medtronic
Boehringer Ingelheim
Julphar
Cantor Fitzgerald
Cerilliant
Harvard Business School

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