AZULFIDINE EN-TABS
Details
- Status
- Prescription
- First Approved
- 1950-06-20
- Routes
- ORAL
- Dosage Forms
- TABLET, DELAYED RELEASE, TABLET
AZULFIDINE EN-TABS Approval History
What AZULFIDINE EN-TABS Treats
3 indicationsAZULFIDINE EN-TABS is approved for 3 conditions since its original approval in 1950. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Ulcerative Colitis
- Rheumatoid Arthritis
- Juvenile 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.
AZULFIDINE EN-TABS FDA Label Details
ProIndications & Usage
FDA Label (PDF)AZULFIDINE EN-tabs Tablets are indicated: a) in the treatment of mild to moderate ulcerative colitis, and as adjunctive therapy in severe ulcerative colitis; b) for the prolongation of the remission period between acute attacks of ulcerative colitis; c) in the treatment of patients with rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs (e.g., an insufficient therapeutic response to, or intolerance of, an adequate trial of full doses of one or more nonsteroidal anti-inflammatory drugs); and d) in the treatment of pediatric patients...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.