Data updated: Mar 10, 2026

SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE

Q: What is SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE used for?

SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE is an FDA-approved medication. See full prescribing information for approved uses.

Q: Is SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE FDA approved?

Yes, SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE is FDA approved (first approved 1993-05-27) and manufactured by GENUS.

Q: Who makes SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE?

SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE is manufactured by GENUS.

PREDNISOLONE SODIUM PHOSPHATE

Approved 1993-05-27

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Indications

Phase 3 Trials

Years on Market

Details

Status: Discontinued
First Approved: 1993-05-27
Routes: OPHTHALMIC
Dosage Forms: SOLUTION/DROPS

Companies

GENUS BAUSCH AND LOMB

Active Ingredient: PREDNISOLONE SODIUM PHOSPHATE , SULFACETAMIDE SODIUM

SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE Approval History

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What SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE Treats

2 FDA approvals

Originally approved for its first indication in 1993 . Covers 2 distinct patient populations.

Other (2)

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Active Pipeline

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Ongoing clinical trials by development phase

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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

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 AND PREDNISOLONE SODIUM PHOSPHATE FDA Label Details

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Data Sources

FDA Approval: ANDA073630 → Trials: ClinicalTrials.gov →

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