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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 050479

CORTISPORIN (HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE)
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Proprietary Name: CORTISPORIN
Dosage Form; Route of Administration: SOLUTION/DROPS; OTIC
Strength: 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N050479
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: MONARCH PHARMACEUTICALS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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