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Details for New Drug Application (NDA): 078126

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NDA 078126 describes FOSPHENYTOIN SODIUM, which is a drug marketed by Sun Pharma Global, Apotex Inc, Mylan Labs Ltd, Wockhardt, Fresenius Kabi Usa, Hospira, Hikma Farmaceutica, Amneal Pharms Co, Luitpold, Eurohlth Intl Sarl, and Teva Pharms Usa, and is included in thirteen NDAs. It is available from nine suppliers. Additional details are available on the FOSPHENYTOIN SODIUM profile page.

The generic ingredient in FOSPHENYTOIN SODIUM is fosphenytoin sodium. There are seven drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the fosphenytoin sodium profile page.

Summary for NDA: 078126

Apotex Inc
fosphenytoin sodium
Therapeutic Class:Anticonvulsants

Summary for product number 001

Approval Date:Aug 6, 2007TE:RLD:No

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