DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE
Details
- Status
- Prescription
- First Approved
- 2003-04-11
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE Approval History
What DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE Treats
10 indicationsDEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE is approved for 10 conditions since its original approval in 2003. 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
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
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.
DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE FDA Label Details
ProIndications & Usage
FDA Label (PDF)INDICATIONS A. Intravenous or intramuscular administration. When oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, those products labeled for intravenous or intramuscular use are indicated as follows: 1. Endocrine disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importa...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.