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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 215403

ACETAMINOPHEN (ACETAMINOPHEN)
1GM/100ML (10MG/ML)
Marketing Status: Prescription
Active Ingredient: ACETAMINOPHEN
Proprietary Name: ACETAMINOPHEN
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 1GM/100ML (10MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A215403
Product Number: 001
Approval Date: May 3, 2023
Applicant Holder Full Name: INFORLIFE SA
Marketing Status:  Prescription
Patent and Exclusivity Information
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