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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 078417

FOSPHENYTOIN SODIUM (FOSPHENYTOIN SODIUM)
EQ 50MG PHENYTOIN NA/ML
Marketing Status: Prescription
Active Ingredient: FOSPHENYTOIN SODIUM
Proprietary Name: FOSPHENYTOIN SODIUM
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 50MG PHENYTOIN NA/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A078417
Product Number: 001
Approval Date: Mar 18, 2008
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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