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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 078649

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NDA 078649 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 nine 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 078649

Tradename:	SULFACETAMIDE SODIUM
Applicant:	Padagis Us
Ingredient:	sulfacetamide sodium
Patents:	0

Pharmacology for NDA: 078649

Medical Subject Heading (MeSH) Categories for 078649

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

Suppliers and Packaging for NDA: 078649

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SULFACETAMIDE SODIUM	sulfacetamide sodium	LOTION;TOPICAL	078649	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-896	45802-896-26	118 mL in 1 BOTTLE, PLASTIC (45802-896-26)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	LOTION;TOPICAL			Strength	10%
Approval Date:	Mar 23, 2009	TE:	AB	RLD:	No

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