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Data updated: Jul 17, 2026

DEXAMETHASONE SODIUM PHOSPHATE · WATSON LABS INC

Generic · see DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE
Ophthalmology Approved 1962-07-11

DEXAMETHASONE SODIUM PHOSPHATE is FDA-approved to treat 10 conditions (same as DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
29
Indications
--
Phase 3 Trials
64
Years on Market

Details

Status
Prescription
First Approved
1962-07-11
Routes
INJECTION, OPHTHALMIC, OPHTHALMIC, OTIC, Injection, OTIC
Dosage Forms
INJECTABLE, SOLUTION/DROPS, Injectable

Companies

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

DEXAMETHASONE SODIUM PHOSPHATE Approval History

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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

10 indications

DEXAMETHASONE SODIUM PHOSPHATE is approved for 10 conditions since its original approval in 1974. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Adrenocortical Insufficiency
  • Acute Adrenocortical Insufficiency
  • Congenital Adrenal Hyperplasia
  • Nonsuppurative Thyroiditis
  • Hypercalcemia associated with cancer
  • Post-Traumatic Osteoarthritis
  • Synovitis
  • Rheumatoid Arthritis
  • Acute Bursitis
  • Epicondylitis

Same approved indications as DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE (same active ingredient).

Source: FDA Label
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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

Indications & Usage

FDA Label (PDF)

DEXAMETHASONE SODIUM PHOSPHATE is FDA-approved to treat 10 conditions — same approved indications as DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE.

Looking for the branded version?

DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE

Full clinical data, patents, trials, and competitive landscape for dexamethasone sodium phosphate.

See DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE

Data Sources

FDA Approval: ANDA083702 → Trials: ClinicalTrials.gov →

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