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Generated: November 14, 2018

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Details for New Drug Application (NDA): 040684

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NDA 040684 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-seven 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. Thirty-nine suppliers are listed for this compound. Additional details are available on the phenytoin sodium profile page.
Summary for 040684
Tradename:EXTENDED PHENYTOIN SODIUM
Applicant:Taro
Ingredient:phenytoin sodium
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 040684
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EXTENDED PHENYTOIN SODIUM phenytoin sodium CAPSULE;ORAL 040684 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-8020 0615-8020-30 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8020-30) > 5 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK
EXTENDED PHENYTOIN SODIUM phenytoin sodium CAPSULE;ORAL 040684 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-8020 0615-8020-39 30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0615-8020-39)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG EXTENDED
Approval Date:Sep 5, 2006TE:ABRLD:No

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