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Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078476

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NDA 078476 describes FOSPHENYTOIN SODIUM, which is a drug marketed by Amneal Pharms Co, Apotex Inc, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Luitpold, Mylan Labs Ltd, Sun Pharma Global, Teva Pharms Usa, West-ward Pharms Int, and Wockhardt, and is included in thirteen NDAs. It is available from seven 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. Eight suppliers are listed for this compound. Additional details are available on the fosphenytoin sodium profile page.
Summary for 078476
Applicant:Amneal Pharms Co
Ingredient:fosphenytoin sodium
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 078476
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FOSPHENYTOIN SODIUM fosphenytoin sodium INJECTABLE;INJECTION 078476 ANDA Amneal Pharmaceuticals of New York, LLC 65162-998 65162-998-25 25 VIAL in 1 CARTON (65162-998-25) > 2 mL in 1 VIAL (65162-998-01)
FOSPHENYTOIN SODIUM fosphenytoin sodium INJECTABLE;INJECTION 078476 ANDA Amneal Pharmaceuticals of New York, LLC 65162-999 65162-999-10 10 VIAL in 1 CARTON (65162-999-10) > 2 mL in 1 VIAL (65162-999-01)

Profile for product number 001

Approval Date:Mar 18, 2008TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

US Army
Queensland Health
Daiichi Sankyo

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