Details for New Drug Application (NDA): 050417

NDA 050417 describes LUMI-SPORYN, which is a drug marketed by Casper Pharma Llc and is included in one NDA. It is available from two suppliers. 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. Four suppliers are listed for this compound. Additional details are available on the bacitracin zinc; neomycin sulfate; polymyxin b sulfate profile page.

Summary for 050417

Tradename:	LUMI-SPORYN
Applicant:	Casper Pharma Llc
Ingredient:	bacitracin zinc; neomycin sulfate; polymyxin b sulfate
Patents:	0

Pharmacology for NDA: 050417

Physiological Effect

Decreased Cell Wall Synthesis & Repair

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 AUTHORIZED GENERIC	Rising Pharma Holdings, Inc.	16571-754	16571-754-53	1 TUBE in 1 CARTON (16571-754-53) / 3.5 g in 1 TUBE
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:	RX	Dosage:	OINTMENT;OPHTHALMIC			Strength	EQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons**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, 1982	TE:	AT	RLD:	Yes

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