PREDNISONE INTENSOL
Details
- Status
- Prescription
- First Approved
- 1985-02-20
- Routes
- ORAL
- Dosage Forms
- SOLUTION
PREDNISONE INTENSOL Approval History
What PREDNISONE INTENSOL Treats
9 indicationsPREDNISONE INTENSOL is approved for 9 conditions since its original approval in 1985. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Adrenocortical Insufficiency
- Congenital Adrenal Hyperplasia
- Hypercalcemia
- Thyroiditis
- Psoriatic Arthritis
- Rheumatoid Arthritis
- Ankylosing Spondylitis
- Tenosynovitis
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Active Pipeline
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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.
PREDNISONE INTENSOL FDA Label Details
ProIndications & Usage
INDICATIONS Prednisone tablets are indicated in the following conditions: 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance) Congenital adrenal hyperplasia Hypercalcemia associated with cancer Nonsuppurative thyroiditis 2. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriati...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.