DIPROLENE (betamethasone dipropionate) · Merck
Diprolene is a corticosteroid ointment used to help patients with skin conditions that respond to steroid therapy. It treats the redness, swelling, and itching associated with these various skin disorders. This medication is suitable for adults and children who are at least 13 years old.
How DIPROLENE Works
This medication works by influencing cellular signaling, immune function, and protein regulation to manage inflammation. While its exact mechanism for skin conditions is not fully understood, these processes help reduce skin irritation and itching.
Details
- Status
- Discontinued
- First Approved
- 1983-07-27
- Routes
- TOPICAL
- Dosage Forms
- LOTION, AUGMENTED, OINTMENT, AUGMENTED, CREAM, AUGMENTED, GEL, AUGMENTED
DIPROLENE Approval History
What DIPROLENE Treats
1 indicationsDIPROLENE is approved for 1 conditions since its original approval in 1983. These indications span multiple therapeutic areas including oncology, immunology, and more.
DIPROLENE Competitive Set
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Indication competitors
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Merck's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06332612 MROSF | 8420224AROM | Ph 1, Ph 2 | completed | Metformin Repurposing in Oral Submucous Fibrosis: Unveiling In Vitro Signaling Pathways, Progressing to Clinical Trial |
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.
DIPROLENE FDA Label Details
Indications & Usage
FDA Label (PDF)DIPROLENE ® Ointment is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older. DIPROLENE Ointment is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age and older.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.