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Last Updated: December 9, 2019

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Details for New Drug Application (NDA): 050167

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NDA 050167 describes POLYSPORIN, which is a drug marketed by Glaxosmithkline and Monarch Pharms and is included in two NDAs. Additional details are available on the POLYSPORIN profile page.

The generic ingredient in POLYSPORIN is bacitracin zinc; polymyxin b sulfate. There are twenty-seven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the bacitracin zinc; polymyxin b sulfate profile page.
Summary for 050167
Tradename:POLYSPORIN
Applicant:Glaxosmithkline
Ingredient:bacitracin zinc; polymyxin b sulfate
Patents:0

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:AEROSOL;TOPICALStrength10,000 UNITS/GM;2,000,000 UNITS/GM
Approval Date:Mar 1, 1985TE:RLD:No

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