CROMOLYN SODIUM
Details
- Status
- Prescription
- First Approved
- 1994-04-26
- Routes
- ORAL, INHALATION, NASAL, OPHTHALMIC
- Dosage Forms
- CONCENTRATE, SOLUTION, SPRAY, METERED, SOLUTION/DROPS
Companies
CROMOLYN SODIUM Approval History
What CROMOLYN SODIUM Treats
3 indicationsCROMOLYN SODIUM is approved for 3 conditions since its original approval in 1994. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Vernal Keratoconjunctivitis
- Vernal Conjunctivitis
- Vernal Keratitis
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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.
CROMOLYN SODIUM FDA Label Details
ProIndications & Usage
FDA Label (PDF)Cromolyn Sodium Ophthalmic Solution USP, 4% is indicated in the treatment of vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.