TheraRadar
Data updated: May 26, 2026

SULFACETAMIDE SODIUM

Ophthalmology Approved 1971-12-22

SULFACETAMIDE SODIUM is indicated for the treatment of Conjunctivitis; Ocular Infections; Trachoma.

Source: FDA Label • FOUGERA PHARMS
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
8
Indications
--
Phase 3 Trials
54
Years on Market

Details

Status
Prescription
First Approved
1971-12-22
Routes
TOPICAL, OPHTHALMIC
Dosage Forms
LOTION, SOLUTION/DROPS, OINTMENT

Companies

FOUGERA PHARMS PHARMOBEDIENT Novartis BAUSCH AND LOMB EPIC PHARMA LLC PHARMAFAIR CHARTWELL RX SUN PHARMA CANADA PADAGIS US
Active Ingredient: SULFACETAMIDE SODIUM

SULFACETAMIDE SODIUM Approval History

1972
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Original
New Indication
New Form
Label Update
57 FDA actions from 1971 to 2016
Jan 2016 SUPPL
Label · Labeling
Apr 2015 SUPPL
Label · Labeling
Nov 2012 SUPPL
Label · Labeling

What SULFACETAMIDE SODIUM Treats

3 indications

SULFACETAMIDE SODIUM is approved for 3 conditions since its original approval in 1971. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Conjunctivitis
  • Ocular Infections
  • Trachoma
Source: FDA Label

SULFACETAMIDE SODIUM Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

4

Same indication, different mechanism — what else might this patient receive?

CIPRODEX
Novartis
2003 2 indic.
OCUFLOX
AbbVie
1993 2 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to SULFACETAMIDE SODIUM

3 of 8

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

ACTICLATE
DOXYCYCLINE HYCLATE
1 shared
CHARTWELL RX
Shared indications:
Trachoma
CIPRODEX
CIPROFLOXACIN
1 shared
Novartis
Shared indications:
Conjunctivitis
DOXY 200
DOXYCYCLINE HYCLATE
1 shared
Fresenius Kabi
Shared indications:
Trachoma
View all 8 similar drugs Pro
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Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

SULFACETAMIDE SODIUM FDA Label Details

Indications & Usage

SULFACETAMIDE SODIUM is indicated for the treatment of Conjunctivitis; Ocular Infections; Trachoma.

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Data Sources

FDA Approval: ANDA077015 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.