TheraRadar
Data updated: Jun 28, 2026

DEXAMETHASONE SODIUM PHOSPHATE

Ophthalmology Approved 1958-10-30
Jump to: Indications Approvals Trials Competitors Safety Patents
29
Indications
--
Phase 3 Trials
67
Years on Market

Details

Status
Prescription
First Approved
1958-10-30
Routes
INJECTION, OTIC, Injection, OPHTHALMIC, OPHTHALMIC, OTIC
Dosage Forms
INJECTABLE, SOLUTION/DROPS, Injectable

Companies

WATSON LABS INC EPIC PHARMA LLC INTL MEDICATION QUAD PHARMS EUGIA PHARMA GLAND MICRO LABS LTD AMNEAL DELL LABS SOLA BARNES HIND CAPLIN Dr. Reddy's Fresenius Kabi BAUSCH AND LOMB INC Viatris Teva LYPHOMED LUITPOLD GENEYORK PHARMS Pfizer SOMERSET THERAPS LLC Hikma BEL MAR SOMERSET
Active Ingredient: DEXAMETHASONE SODIUM PHOSPHATE

DEXAMETHASONE SODIUM PHOSPHATE Approval History

1975
1976
1977
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2026
Original
New Indication
New Form
Label Update
232 FDA actions from 1974 to 2025
Jul 2025 SUPPL
Label · Labeling
Jun 2025 SUPPL
Label · Labeling
Apr 2025 SUPPL
Label · Labeling

What DEXAMETHASONE SODIUM PHOSPHATE Treats

29 FDA approvals

Originally approved for its first indication in 1974 . Covers 29 distinct patient populations.

  • Other (29)
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Clinical Trial Registry

9 trials
Trial Sponsor ID Phase Status Title
NCT06664853 OLE_NEAT results posted IEDAT-05-2024 Ph 3 terminated Open-Label Extension of EryDex Study IEDAT-04-2022
NCT06193200 NEAT results posted IEDAT-04-2022 Ph 3 completed Evaluate the Neurological Effects of EryDex on Subjects With A-T
NCT03031730 results posted NCI-2017-00099 NCI-2017-00099, NCI10076 Ph 1 terminated Testing the Addition of KRT-232 (AMG 232) to Usual Chemotherapy for Relapsed Multiple Myeloma
NCT04537026 IRB 131761 Ph 1, Ph 2 completed Sterile Amniotic Fluid Filtrate Epidural Injection.
NCT06951087 2019-K068 81974129, 82171038, 82101101 Ph 3 enrolling by invitation Intravitreal and Intracameral DEX in NPDR
NCT03606980 results posted CHKDSM-001 Ph 2 terminated Iontophoresis With Dexamethasone and Physical Therapy to Treat Apophysitis of the Knee in Pediatrics
NCT03332316 R17104M 2017-002185-51 Ph 4 completed Effect of Perineural Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Ankle Surgery
NCT02421419 results posted IRB - 001858 Ph 4 terminated Pain With Trigger Finger Injection: A Comparison of Steroid Alone Versus Steroid/Lidocaine Mixture
NCT01030601 IDDMECS IDDMECS Ph 2 completed Analysis of the Effect of Intravitreal Dexamethasone Injection on Diabetic Macular Edema After Cataract Surgery (IDDMECS)
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

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.

DEXAMETHASONE SODIUM PHOSPHATE FDA Label Details

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Data Sources

FDA Approval: ANDA084355 → Trials: ClinicalTrials.gov →

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