Data updated: Mar 10, 2026
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
ACETAMINOPHEN
Approved 1985-06-12
20
Indications
--
Phase 3 Trials
40
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1985-06-12
- Routes
- ORAL
- Dosage Forms
- TABLET
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN Approval History
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What PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN Treats
20 FDA approvalsOriginally approved for its first indication in 1985 . Covers 20 distinct patient populations.
- Other (20)
Other
(20 approvals)- • Approved indication (Jun 1985)
- • Approved indication (Aug 1985)
- • Approved indication (Oct 1985)
- • Approved indication (Mar 1986)
- • Approved indication (Jun 1986)
- • Approved indication (Jan 1987)
- • Approved indication (Jan 1987)
- • Approved indication (Jan 1987)
- • Approved indication (Feb 1988)
- • Approved indication (May 1988)
- • Approved indication (Dec 1994)
- • Approved indication (Feb 1997)
- • Approved indication (Feb 2001)Letter
- • Approved indication (Jul 2001)
- • Approved indication (May 2004)
- • Approved indication (Jun 2004)
- • Approved indication (Nov 2004)
- • Approved indication (Jun 2005)
- • Approved indication (Mar 2007)
- • Approved indication (Feb 2008)
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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.
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.