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Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078765

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NDA 078765 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 six 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. Seven suppliers are listed for this compound. Additional details are available on the fosphenytoin sodium profile page.

Summary for 078765

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

Suppliers and Packaging for NDA: 078765

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FOSPHENYTOIN SODIUM fosphenytoin sodium INJECTABLE;INJECTION 078765 ANDA West-Ward Pharmaceuticals Corp 0143-9782 0143-9782-10 10 VIAL in 1 PACKAGE (0143-9782-10) > 10 mL in 1 VIAL (0143-9782-01)
FOSPHENYTOIN SODIUM fosphenytoin sodium INJECTABLE;INJECTION 078765 ANDA West-Ward Pharmaceuticals Corp 0143-9788 0143-9788-25 25 VIAL in 1 PACKAGE (0143-9788-25) > 2 mL in 1 VIAL (0143-9788-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 50MG PHENYTOIN NA/ML
Approval Date:Dec 2, 2009TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

Citi
Accenture
Novartis
Deloitte
Colorcon
Boehringer Ingelheim
Johnson and Johnson
Federal Trade Commission
Julphar
Cantor Fitzgerald

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