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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 216601

PHYTONADIONE (PHYTONADIONE)
1MG/0.5ML
Marketing Status: Prescription
Active Ingredient: PHYTONADIONE
Proprietary Name: PHYTONADIONE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1MG/0.5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A216601
Product Number: 001
Approval Date: Nov 4, 2025
Applicant Holder Full Name: AMNEAL EU LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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