Data updated: May 26, 2026
DOLOBID (diflunisal)
Pain
Approved 1982-04-19
1
Indication
--
Phase 3 Trials
1
Priority Reviews
44
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1982-04-19
- Routes
- ORAL
- Dosage Forms
- TABLET
DOLOBID Approval History
1983
1984
1985
1986
1987
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
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2001
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2026
Original
New Indication
New Form
Label Update
88 FDA actions from 1982 to 2007
May 1998 SUPPL Priority
Label · Labeling
Dec 1997 SUPPL Priority
Mfg
Apr 1997 SUPPL Priority
Label
Mar 1996 SUPPL Priority
Mfg
Aug 1994 SUPPL Priority
Label
Aug 1994 SUPPL Priority
Mfg
Mar 1994 SUPPL Priority
Mfg
Dec 1991 SUPPL Priority
Mfg
Nov 1991 SUPPL Priority
Mfg
Apr 1989 SUPPL Priority
Mfg
Jan 1989 SUPPL Priority
Mfg
May 1988 SUPPL Priority
Mfg
Feb 1988 SUPPL Priority
Label
Aug 1986 SUPPL Priority
Label
Feb 1986 SUPPL Priority
Mfg
Sep 1985 SUPPL Priority
Mfg
Feb 1985 SUPPL Priority
Mfg
Jan 1985 SUPPL Priority
Label
Dec 1984 SUPPL Priority
Mfg
Nov 1984 SUPPL Priority
Mfg
Oct 1984 SUPPL Priority
Mfg
Jun 1984 SUPPL Priority
Mfg
May 1984 SUPPL Priority
Mfg
Oct 1983 SUPPL Priority
Label
Apr 1982 ORIGINAL Priority
New Drug
What DOLOBID Treats
1 FDA approvalsOriginally approved for its first indication in 1982 .
- Other (1)
Other
(1 approval)- • Approved indication (Apr 1982) Priority
📋
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 |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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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.
DOLOBID FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.