Data updated: Mar 10, 2026
DEXAMETHASONE SODIUM PHOSPHATE
DEXAMETHASONE SODIUM PHOSPHATE
Approved 1974-12-19
29
Indications
--
Phase 3 Trials
51
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1974-12-19
- Routes
- OPHTHALMIC, INJECTION, Injection, OPHTHALMIC, OTIC, OTIC
- Dosage Forms
- SOLUTION/DROPS, INJECTABLE, Injectable
Companies
SOLA BARNES HIND Fresenius Kabi LUITPOLD Hikma QUAD PHARMS EUGIA PHARMA GENEYORK PHARMS Viatris Pfizer SOMERSET THERAPS LLC GLAND WATSON LABS Dr. Reddy's AMNEAL MICRO LABS Teva EPIC PHARMA LLC INTL MEDICATION CAPLIN SOMERSET LYPHOMED BAUSCH AND LOMB DELL LABS BEL MAR
Active Ingredient: DEXAMETHASONE SODIUM PHOSPHATE
Website: ↗
DEXAMETHASONE SODIUM PHOSPHATE Approval History
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What DEXAMETHASONE SODIUM PHOSPHATE Treats
29 FDA approvalsOriginally approved for its first indication in 1974 . Covers 29 distinct patient populations.
- Other (29)
Other
(29 approvals)- • Approved indication (Dec 1974)
- • Approved indication (Feb 1975)
- • Approved indication (Jul 1975)
- • Approved indication (Jun 1976)
- • Approved indication (Sep 1977)
- • Approved indication (Jun 1978)
- • Approved indication (Mar 1979)
- • Approved indication (May 1981)
- • Approved indication (Jul 1982)
- • Approved indication (Jul 1982)
- • Approved indication (Sep 1982)
- • Approved indication (Jan 1985)
- • Approved indication (Apr 1986)
- • Approved indication (Aug 1990)
- • Approved indication (Jul 1996)
- • Approved indication (Apr 2005)
- • Approved indication (Aug 2008)
- • Approved indication (Sep 2015)
- • Approved indication (Dec 2015)Letter
- • Approved indication (Jun 2018)
- • Approved indication (Jul 2018)
- • Approved indication (Aug 2018)
- • Approved indication (May 2019)
- • Approved indication (Jun 2019)
- • Approved indication (Jun 2020)
- • Approved indication (Aug 2021)
- • Approved indication (Jul 2023)
- • Approved indication (Aug 2023)
- • Approved indication (Mar 2024)
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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
Data sourced from official FDA and NIH databases. Click links to verify on original sources.