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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 050344

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NDA 050344 describes STATROL, which is a drug marketed by Alcon and is included in three NDAs. Additional details are available on the STATROL profile page.

The generic ingredient in STATROL is neomycin sulfate; polymyxin b sulfate. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the neomycin sulfate; polymyxin b sulfate profile page.

Summary for 050344

Tradename:	STATROL
Applicant:	Alcon
Ingredient:	neomycin sulfate; polymyxin b sulfate
Patents:	0

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	OINTMENT;OPHTHALMIC			Strength	EQ 3.5MG BASE/GM;10,000 UNITS/GM
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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