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Last Updated: October 18, 2021

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Details for New Drug Application (NDA): 050417

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NDA 050417 describes LUMI-SPORYN, which is a drug marketed by Casper Pharma Llc and is included in one NDA. It is available from one supplier. Additional details are available on the LUMI-SPORYN profile page.

The generic ingredient in LUMI-SPORYN is bacitracin zinc; neomycin sulfate; polymyxin b sulfate. There are twenty-seven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the bacitracin zinc; neomycin sulfate; polymyxin b sulfate profile page.
Summary for 050417
Pharmacology for NDA: 050417
Suppliers and Packaging for NDA: 050417
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LUMI-SPORYN bacitracin zinc; neomycin sulfate; polymyxin b sulfate OINTMENT;OPHTHALMIC 050417 NDA Casper Pharma LLC 70199-010 70199-010-53 1 TUBE in 1 CARTON (70199-010-53) > 3.5 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;OPHTHALMICStrengthEQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:ATRLD:Yes

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Express Scripts
Harvard Business School

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