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Last Updated: December 30, 2025

Details for New Drug Application (NDA): 089560

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NDA 089560 describes SULFACETAMIDE SODIUM, which is a drug marketed by Fougera Pharms, Padagis Us, Sun Pharma Canada, Alcon Pharms Ltd, Bausch And Lomb, Chartwell Rx, Epic Pharma Llc, Pharmafair, Pharmobedient, and Genus, and is included in twelve NDAs. It is available from eight suppliers. Additional details are available on the SULFACETAMIDE SODIUM profile page.

The generic ingredient in SULFACETAMIDE SODIUM is prednisolone sodium phosphate; sulfacetamide sodium. There are eighty-eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the prednisolone sodium phosphate; sulfacetamide sodium profile page.

Summary for 089560

Tradename:	SULFACETAMIDE SODIUM
Applicant:	Chartwell Rx
Ingredient:	sulfacetamide sodium
Patents:	0

Pharmacology for NDA: 089560

Medical Subject Heading (MeSH) Categories for 089560

Anti-Infective Agents, Local
Anti-Infective Agents, Urinary

Suppliers and Packaging for NDA: 089560

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SULFACETAMIDE SODIUM	sulfacetamide sodium	SOLUTION/DROPS;OPHTHALMIC	089560	ANDA	Redpharm Drug	67296-0403	67296-0403-1	15 mL in 1 BOTTLE, PLASTIC (67296-0403-1)
SULFACETAMIDE SODIUM	sulfacetamide sodium	SOLUTION/DROPS;OPHTHALMIC	089560	ANDA	Asclemed USA, Inc.	76420-076	76420-076-15	15 mL in 1 BOTTLE, PLASTIC (76420-076-15)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	10%
Approval Date:	Oct 18, 1988	TE:	AT	RLD:	No

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