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Details for New Drug Application (NDA): 040731

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NDA 040731 describes EXTENDED PHENYTOIN SODIUM, which is a drug marketed by Sun Pharm Inds (in), Sun Pharm Inds, Wockhardt Usa, Ani Pharms Inc, Wockhardt, Amneal Pharms Ny, Taro, and Mylan, 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.

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 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 Limited 62756-299 62756-299-13 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62756-299-13)

Summary for product number 001

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

Summary for product number 002

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


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