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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 050176

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NDA 050176 describes NEOSPORIN, which is a drug marketed by Glaxosmithkline and Monarch Pharms and is included in three NDAs. Additional details are available on the NEOSPORIN profile page.

The generic ingredient in NEOSPORIN is gramicidin; neomycin sulfate; polymyxin b sulfate. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the gramicidin; neomycin sulfate; polymyxin b sulfate profile page.

Summary for 050176

Tradename:	NEOSPORIN
Applicant:	Glaxosmithkline
Ingredient:	neomycin sulfate; polymyxin b sulfate
Patents:	0

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CREAM;TOPICAL			Strength	EQ 3.5MG BASE/GM;10,000 UNITS/GM
Approval Date:	Jan 14, 1985	TE:		RLD:	No

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