DOLOBID (diflunisal) · Merck
DOLOBID is FDA-approved to treat 3 conditions (same as DIFLUNISAL).
Details
- Status
- Discontinued
- First Approved
- 1982-04-19
- Routes
- ORAL
- Dosage Forms
- TABLET
DOLOBID Approval History
What DOLOBID Treats
3 indicationsDOLOBID is approved for 3 conditions since its original approval in 1982. These indications span multiple therapeutic areas including oncology, immunology, and more.
Same approved indications as DIFLUNISAL (same active ingredient).
Merck's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04113668 | IM011-101 | Ph 1 | completed | The Effects Diflunisal on the Levels of BMS-986165 in Healthy Participants |
| NCT01676363 | H11-03547 H11-03547 | Ph 4 | terminated | Pilot Study of Diflunisal in HIV-infected Adults |
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.
DOLOBID FDA Label Details
Indications & Usage
FDA Label (PDF)DOLOBID is FDA-approved to treat 3 conditions — same approved indications as DIFLUNISAL.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.