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Data updated: Mar 10, 2026

AZULFIDINE EN-TABS

SULFASALAZINE
Immunology Approved 1950-06-20
2
Indications
--
Phase 3 Trials
1
Priority Reviews
75
Years on Market

Details

Status
Prescription
First Approved
1950-06-20
Routes
ORAL
Dosage Forms
TABLET, DELAYED RELEASE, TABLET

Companies

Active Ingredient: SULFASALAZINE

AZULFIDINE EN-TABS Approval History

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What AZULFIDINE EN-TABS Treats

3 indications

AZULFIDINE 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
Source: FDA Label

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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.

AZULFIDINE EN-TABS FDA Label Details

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Indications & 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.