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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Express Scripts
Farmers Insurance
Dow
Teva
Johnson and Johnson
AstraZeneca
Cipla
Baxter

Generated: May 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078052

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NDA 078052 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 078052
Tradename:FOSPHENYTOIN SODIUM
Applicant:Fresenius Kabi Usa
Ingredient:fosphenytoin sodium
Patents:0
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 078052
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FOSPHENYTOIN SODIUM fosphenytoin sodium INJECTABLE;INJECTION 078052 ANDA Fresenius Kabi USA, LLC 63323-403 N 63323-403-02
FOSPHENYTOIN SODIUM fosphenytoin sodium INJECTABLE;INJECTION 078052 ANDA Fresenius Kabi USA, LLC 63323-403 N 63323-403-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 50MG PHENYTOIN NA/ML
Approval Date:Aug 6, 2007TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
US Army
Cipla
Teva
AstraZeneca
Merck
Baxter
Chubb
Accenture

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