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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Fish and Richardson

Generated: March 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 085435

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NDA 085435 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 nineteen 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 085435
Ingredient:phenytoin sodium
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength100MG PROMPT
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Chinese Patent Office
Daiichi Sankyo

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