FLUDROCORTISONE ACETATE
Details
- Status
- Prescription
- First Approved
- 2002-03-18
- Routes
- ORAL
- Dosage Forms
- TABLET
FLUDROCORTISONE ACETATE Approval History
What FLUDROCORTISONE ACETATE Treats
3 indicationsFLUDROCORTISONE ACETATE is approved for 3 conditions since its original approval in 2002. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Adrenocortical Insufficiency
- Addison's Disease
- Adrenogenital Syndrome
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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.
FLUDROCORTISONE ACETATE FDA Label Details
ProIndications & Usage
Fludrocortisone acetate tablets, 0.1 mg are indicated as partial replacement therapy for primary and secondary adrenocortical insufficiency in Addison's disease and for the treatment of salt-losing adrenogenital syndrome.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.