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Last Updated: July 13, 2020

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, Lupin Ltd, Mylan, Sun Pharm Inds, Sun Pharm Inds (in), Taro, Wockhardt, and Wockhardt Usa, and is included in ten NDAs. It is available from nineteen suppliers. Additional details are available on the EXTENDED PHENYTOIN SODIUM profile page.

The generic ingredient in EXTENDED PHENYTOIN SODIUM is phenytoin sodium. There are twenty-one drug master file entries for this compound. Twenty-five 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
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, Inc. 62756-299 62756-299-08 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62756-299-08)
EXTENDED PHENYTOIN SODIUM phenytoin sodium CAPSULE;ORAL 040731 ANDA Sun Pharmaceutical Industries, Inc. 62756-299 62756-299-13 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62756-299-13)

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 leading biopharmaceutical companies globally:

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