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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 040765

EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM)
100MG EXTENDED
Marketing Status: Prescription
Active Ingredient: PHENYTOIN SODIUM
Proprietary Name: EXTENDED PHENYTOIN SODIUM
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 100MG EXTENDED
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A040765
Product Number: 001
Approval Date: Nov 12, 2008
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS NY LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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