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Generated: April 24, 2017

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Details for New Drug Application (NDA): 077989

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NDA 077989 describes FOSPHENYTOIN SODIUM, which is a drug marketed by Sun Pharma Global, Apotex Inc, Mylan Labs Ltd, Wockhardt, Fresenius Kabi Usa, Hospira, Hikma Farmaceutica, Amneal Pharms Co, Luitpold, West-ward Pharms Int, and Teva Pharms Usa, and is included in thirteen NDAs. It is available from nine 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. Eleven suppliers are listed for this compound. Additional details are available on the fosphenytoin sodium profile page.

Summary for NDA: 077989

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
INJECTABLE;INJECTION 077989 ANDA West-Ward Pharmaceuticals Corp. 0641-6136 0641-6136-25 25 VIAL in 1 CARTON (0641-6136-25) > 2 mL in 1 VIAL (0641-6136-01)
fosphenytoin sodium
INJECTABLE;INJECTION 077989 ANDA West-Ward Pharmaceuticals Corp. 0641-6137 0641-6137-10 10 VIAL in 1 CARTON (0641-6137-10) > 10 mL in 1 VIAL (0641-6137-01)

Summary for product number 001

Approval Date:Aug 6, 2007TE:APRLD:No

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