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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 202402

IBUPROFEN LYSINE (IBUPROFEN LYSINE)
EQ 20MG BASE/2ML (EQ 10MG BASE/ML)
Marketing Status: Prescription
Active Ingredient: IBUPROFEN LYSINE
Proprietary Name: IBUPROFEN LYSINE
Dosage Form; Route of Administration: INJECTABLE; INTRAVENOUS
Strength: EQ 20MG BASE/2ML (EQ 10MG BASE/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A202402
Product Number: 001
Approval Date: Mar 30, 2016
Applicant Holder Full Name: XGEN PHARMACEUTICALS DJB INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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