Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022450

OFIRMEV (ACETAMINOPHEN)
1GM/100ML (10MG/ML) Marketing Status: Prescription

Active Ingredient: ACETAMINOPHEN
Proprietary Name: OFIRMEV
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 1GM/100ML (10MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N022450
Product Number: 001
Approval Date: Nov 2, 2010
Applicant Holder Full Name: MALLINCKRODT IP
Marketing Status:  Prescription
Patent and Exclusivity Information

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