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Fosphenytoin sodium - Generic Drug Details

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Fosphenytoin sodium is the generic ingredient in two branded drugs marketed by Sun Pharma Global, Apotex Inc, Mylan Labs Ltd, Wockhardt, Parke Davis, Fresenius Kabi Usa, Hospira, Hikma Farmaceutica, Amneal Pharms Co, Luitpold, Eurohlth Intl Sarl, and Teva Pharms Usa, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for fosphenytoin sodium. Eleven suppliers are listed for this compound.

Summary for Generic Name: fosphenytoin sodium

Tradenames:2
Patents:0
Applicants:12
NDAs:14
Drug Master File Entries: see list7
Suppliers / Packaging: see list11
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Drug Prices:see low prices
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Luitpold
FOSPHENYTOIN SODIUM
fosphenytoin sodium
INJECTABLE;INJECTION078277-001Aug 6, 2007RXNo► subscribe► subscribe
Eurohlth Intl Sarl
FOSPHENYTOIN SODIUM
fosphenytoin sodium
INJECTABLE;INJECTION077481-001Aug 6, 2007RXNo► subscribe► subscribe
Fresenius Kabi Usa
FOSPHENYTOIN SODIUM
fosphenytoin sodium
INJECTABLE;INJECTION078052-001Aug 6, 2007DISCNNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: fosphenytoin sodium

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Parke Davis
CEREBYX
fosphenytoin sodium
INJECTABLE;INJECTION020450-001Aug 5, 19964,260,769► subscribe
Parke Davis
CEREBYX
fosphenytoin sodium
INJECTABLE;INJECTION020450-001Aug 5, 19964,925,860► subscribe
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