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Serving leading biopharmaceutical companies globally:

Dow
Fish and Richardson
McKesson
US Army
Baxter
Colorcon
Chinese Patent Office
Healthtrust
Queensland Health
Medtronic

Generated: October 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 089744

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NDA 089744 describes PHENYTOIN SODIUM, which is a drug marketed by Warner Chilcott, Marsam Pharms Llc, Fresenius Kabi Usa, West-ward Pharms Int, Aurobindo Pharma Ltd, Smith And Nephew, Solopak, Hospira, Watson Labs, Pharmeral, Acella Pharms Llc, and Luitpold, and is included in sixteen NDAs. It is available from eight suppliers. Additional details are available on the PHENYTOIN SODIUM profile page.

The generic ingredient in PHENYTOIN SODIUM is phenytoin sodium. There are nineteen drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the phenytoin sodium profile page.

Summary for NDA: 089744

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

Suppliers and Packaging for NDA: 089744

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PHENYTOIN SODIUM
phenytoin sodium
INJECTABLE;INJECTION 089744 ANDA Hospira, Inc. 0409-1844 0409-1844-32 10 CARTRIDGE in 1 BOX (0409-1844-32) > 2 mL in 1 CARTRIDGE

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength50MG/ML
Approval Date:Dec 18, 1987TE:RLD:No


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Serving leading biopharmaceutical companies globally:

Chubb
Queensland Health
Moodys
Mallinckrodt
Farmers Insurance
AstraZeneca
US Department of Justice
Cipla
Medtronic
Boehringer Ingelheim

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