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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 050456

STATROL (NEOMYCIN SULFATE; POLYMYXIN B SULFATE)
EQ 3.5MG BASE/ML;16,250 UNITS/ML
Marketing Status: Discontinued
Active Ingredient: NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Proprietary Name: STATROL
Dosage Form; Route of Administration: SOLUTION/DROPS; OPHTHALMIC
Strength: EQ 3.5MG BASE/ML;16,250 UNITS/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N050456
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ALCON LABORATORIES INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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