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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 204435

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NDA 204435 describes NEOMYCIN SULFATE, which is a drug marketed by Aarxion Anda Hlding, Bristol Myers Squibb, Chartwell Molecular, Lannett, Lilly, Pharmobedient, Roxane, Sandoz, Teva, Bausch And Lomb, Pharmafair, Alcon Pharms Ltd, Fougera, and Pharmaderm, and is included in twenty NDAs. It is available from three suppliers. Additional details are available on the NEOMYCIN SULFATE profile page.

The generic ingredient in NEOMYCIN SULFATE is neomycin sulfate; triamcinolone acetonide. There are nineteen drug master file entries for this compound. Additional details are available on the neomycin sulfate; triamcinolone acetonide profile page.

Summary for 204435

Tradename:	NEOMYCIN SULFATE
Applicant:	Chartwell Molecular
Ingredient:	neomycin sulfate
Patents:	0

Pharmacology for NDA: 204435

Medical Subject Heading (MeSH) Categories for 204435

Anti-Bacterial Agents
Protein Synthesis Inhibitors

Suppliers and Packaging for NDA: 204435

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NEOMYCIN SULFATE	neomycin sulfate	TABLET;ORAL	204435	ANDA	Chartwell RX, LLC	62135-443	62135-443-90	90 TABLET in 1 BOTTLE (62135-443-90)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Jun 10, 2016	TE:		RLD:	No

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