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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 080029

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NDA 080029 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 seven 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 080029

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

Medical Subject Heading (MeSH) Categories for 080029

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	OINTMENT;OPHTHALMIC			Strength	10%
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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