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Generated: September 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076539

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NDA 076539 describes VALPROATE SODIUM, which is a drug marketed by Hikma Farmaceutica, Fresenius Kabi Usa, and Athenex Inc, 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 NDA: 076539

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details

Pharmacology for NDA: 076539

Suppliers and Packaging for NDA: 076539

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALPROATE SODIUM
valproate sodium
INJECTABLE;INJECTION 076539 ANDA Fresenius Kabi USA, LLC 63323-494 63323-494-05 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-494-05) > 5 mL in 1 VIAL, SINGLE-DOSE
VALPROATE SODIUM
valproate sodium
INJECTABLE;INJECTION 076539 ANDA Fresenius Kabi USA, LLC 63323-494 63323-494-16 10 VIAL, SINGLE-USE in 1 TRAY (63323-494-16) > 5 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 100MG BASE/ML
Approval Date:Jun 26, 2003TE:APRLD:No


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Serving 500+ biopharmaceutical companies globally:

Teva
AstraZeneca
Moodys
Dow
Accenture
Cantor Fitzgerald
Queensland Health
McKesson
Mallinckrodt
Baxter

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