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Details for New Drug Application (NDA): 020450

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NDA 020450 describes CEREBYX, which is a drug marketed by Parke Davis and is included in one NDA. It is available from two suppliers. Additional details are available on the CEREBYX profile page.

The generic ingredient in CEREBYX is fosphenytoin sodium. There are seven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the fosphenytoin sodium profile page.

Suppliers and Packaging for NDA: 020450

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEREBYX
fosphenytoin sodium
INJECTABLE;INJECTION 020450 NDA Pfizer Laboratories 0069-5471 0069-5471-02 25 VIAL in 1 CARTON (0069-5471-02) > 2 mL in 1 VIAL (0069-5471-01)
CEREBYX
fosphenytoin sodium
INJECTABLE;INJECTION 020450 NDA Pfizer Laboratories 0069-5474 0069-5474-02 10 VIAL in 1 PACKAGE (0069-5474-02) > 10 mL in 1 VIAL (0069-5474-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 50MG PHENYTOIN NA/ML
Approval Date:Aug 5, 1996TE:APRLD:Yes

Expired Orange Book Patents for NDA: 020450

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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