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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 204309

PHENYTOIN SODIUM (PHENYTOIN SODIUM)
100MG EXTENDED
Marketing Status: Prescription
Active Ingredient: PHENYTOIN SODIUM
Proprietary Name: PHENYTOIN SODIUM
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 100MG EXTENDED
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204309
Product Number: 001
Approval Date: Jun 10, 2015
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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