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Serving leading biopharmaceutical companies globally:

Teva
Baxter
US Army
Citi
Daiichi Sankyo
Boehringer Ingelheim
Merck
QuintilesIMS
Julphar
Healthtrust

Generated: February 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040731

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NDA 040731 describes EXTENDED PHENYTOIN SODIUM, which is a drug marketed by Amneal Pharms Ny, Ani Pharms Inc, Mylan, Sun Pharm Inds, Sun Pharm Inds (in), Taro, Wockhardt, and Wockhardt Usa, and is included in nine NDAs. It is available from twenty-nine suppliers. Additional details are available on the EXTENDED PHENYTOIN SODIUM profile page.

The generic ingredient in EXTENDED PHENYTOIN SODIUM is phenytoin sodium. There are nineteen drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the phenytoin sodium profile page.
Summary for 040731
Tradename:EXTENDED PHENYTOIN SODIUM
Applicant:Sun Pharm Inds
Ingredient:phenytoin sodium
Patents:0
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 040731
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EXTENDED PHENYTOIN SODIUM phenytoin sodium CAPSULE;ORAL 040731 ANDA Sun Pharmaceutical Industries Limited 62756-299 N 62756-299-88
EXTENDED PHENYTOIN SODIUM phenytoin sodium CAPSULE;ORAL 040731 ANDA Sun Pharmaceutical Industries Limited 62756-299 N 62756-299-08

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG EXTENDED
Approval Date:Jun 30, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength300MG EXTENDED
Approval Date:Jun 30, 2008TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Baxter
Harvard Business School
Argus Health
Farmers Insurance
Cantor Fitzgerald
Express Scripts
Chubb
UBS

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