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Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 089779

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NDA 089779 describes PHENYTOIN SODIUM, which is a drug marketed by Aurobindo Pharma Ltd, Pharmeral, Watson Labs, Acella Pharms Llc, Fresenius Kabi Usa, Hospira, Luitpold, Marsam Pharms Llc, Smith And Nephew, Solopak, Warner Chilcott, and West-ward Pharms Int, and is included in sixteen NDAs. It is available from seven suppliers. Additional details are available on the PHENYTOIN SODIUM profile page.

The generic ingredient in PHENYTOIN SODIUM is phenytoin sodium. There are twenty drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the phenytoin sodium profile page.
Summary for 089779
Tradename:PHENYTOIN SODIUM
Applicant:Marsam Pharms Llc
Ingredient:phenytoin sodium
Patents:0
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength50MG/ML
Approval Date:Nov 27, 1992TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Cerilliant
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Baxter
Mallinckrodt
Cipla
Moodys
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US Department of Justice

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