NEO-SYNALAR
Details
- Status
- Prescription
- First Approved
- 1963-06-11
- Routes
- TOPICAL
- Dosage Forms
- CREAM
Companies
NEO-SYNALAR Approval History
What NEO-SYNALAR Treats
2 indicationsNEO-SYNALAR is approved for 2 conditions since its original approval in 1963. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Dermatoses
- Secondary Infection
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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.
NEO-SYNALAR FDA Label Details
ProIndications & Usage
NEO-SYNALAR ® cream is indicated for the treatment of corticosteroid-responsive dermatoses with secondary infection. It has not been demonstrated that this steroid-antibiotic combination provides greater benefit than the steroid component alone after 7 days of treatment (see WARNINGS section) .
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.