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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020450

CEREBYX (FOSPHENYTOIN SODIUM)
EQ 50MG PHENYTOIN NA/ML
Marketing Status: Prescription
Active Ingredient: FOSPHENYTOIN SODIUM
Proprietary Name: CEREBYX
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 50MG PHENYTOIN NA/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N020450
Product Number: 001
Approval Date: Aug 5, 1996
Applicant Holder Full Name: PARKE DAVIS DIV WARNER LAMBERT CO
Marketing Status:  Prescription
Patent and Exclusivity Information
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