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Last Updated: October 20, 2021

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Details for New Drug Application (NDA): 050168


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NDA 050168 describes CORTISPORIN, which is a drug marketed by Monarch Pharms and Casper Pharma Llc and is included in five NDAs. Additional details are available on the CORTISPORIN profile page.

The generic ingredient in CORTISPORIN is hydrocortisone; neomycin sulfate; polymyxin b sulfate. There are sixty-seven drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the hydrocortisone; neomycin sulfate; polymyxin b sulfate profile page.
Summary for 050168

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:OINTMENT;TOPICALStrength400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM
Approval Date:May 4, 1984TE:RLD:Yes

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Express Scripts
Boehringer Ingelheim
McKesson
Johnson and Johnson
Dow

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