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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Covington
Citi
Express Scripts
Fish and Richardson
US Army
Cipla
Dow
Healthtrust

Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077989

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NDA 077989 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 077989
Tradename:FOSPHENYTOIN SODIUM
Applicant:West-ward Pharms Int
Ingredient:fosphenytoin sodium
Patents:0
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 077989
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FOSPHENYTOIN SODIUM fosphenytoin sodium INJECTABLE;INJECTION 077989 ANDA West-Ward Pharmaceuticals Corp. 0641-6136 N 0641-6136-25
FOSPHENYTOIN SODIUM fosphenytoin sodium INJECTABLE;INJECTION 077989 ANDA West-Ward Pharmaceuticals Corp. 0641-6137 N 0641-6137-10

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:

Merck
Queensland Health
UBS
Chinese Patent Office
Accenture
Baxter
US Department of Justice
Daiichi Sankyo
Chubb

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