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FDA Drug Approval, N050479, CORTISPORIN
FDA Drug Approval, N050479, CORTISPORIN
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NDA: 050479
Company: MONARCH PHARMS
Drug Name: CORTISPORIN
Active Ingredients: HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Strength: 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage Form/Route: SOLUTION/DROPS;OTIC
Action Date: 12/09/1975
Marketing Status: Discontinued
Submission Classification: Type 5 - New Formulation or New Manufacturer
Company: MONARCH PHARMS
Drug Name: CORTISPORIN
Active Ingredients: HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Strength: 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage Form/Route: SOLUTION/DROPS;OTIC
Action Date: 12/09/1975
Marketing Status: Discontinued
Submission Classification: Type 5 - New Formulation or New Manufacturer
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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