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Generated: October 17, 2018

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Details for New Drug Application (NDA): 076295

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NDA 076295 describes VALPROATE SODIUM, which is a drug marketed by Athenex Inc, Fresenius Kabi Usa, and Hikma Farmaceutica, and is included in three NDAs. It is available from two suppliers. Additional details are available on the VALPROATE SODIUM profile page.

The generic ingredient in VALPROATE SODIUM is valproate sodium. There are nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the valproate sodium profile page.
Summary for 076295
Tradename:VALPROATE SODIUM
Applicant:Athenex Inc
Ingredient:valproate sodium
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 100MG BASE/ML
Approval Date:Nov 14, 2002TE:APRLD:No

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