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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 060707

NEOSPORIN G.U. IRRIGANT (NEOMYCIN SULFATE; POLYMYXIN B SULFATE)
EQ 40MG BASE/ML;200,000 UNITS/ML
Marketing Status: Prescription
Active Ingredient: NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Proprietary Name: NEOSPORIN G.U. IRRIGANT
Dosage Form; Route of Administration: SOLUTION; IRRIGATION
Strength: EQ 40MG BASE/ML;200,000 UNITS/ML
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AT
Application Number: A060707
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: MONARCH PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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