Data updated: Mar 10, 2026
PROPOXYPHENE HYDROCHLORIDE
PROPOXYPHENE HYDROCHLORIDE
Approved 1971-11-30
19
Indications
--
Phase 3 Trials
54
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1971-11-30
- Routes
- ORAL
- Dosage Forms
- CAPSULE
Companies
WATSON LABS PVT FORM Novartis ALRA Viatris PUREPAC PHARM IVAX SUB TEVA PHARMS VINTAGE PHARMS VALEANT PHARM INTL PAR PHARM ROXANE MUTUAL PHARM Teva NEXGEN PHARMA INC IMPAX LABS WHITEWORTH TOWN PLSN Hikma
Active Ingredient: PROPOXYPHENE HYDROCHLORIDE
Website: ↗
PROPOXYPHENE HYDROCHLORIDE Approval History
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What PROPOXYPHENE HYDROCHLORIDE Treats
19 FDA approvalsOriginally approved for its first indication in 1971 . Covers 19 distinct patient populations.
- Other (19)
Other
(19 approvals)- • Approved indication (Nov 1971)
- • Approved indication (Aug 1972)
- • Approved indication (Oct 1972)
- • Approved indication (Nov 1972)
- • Approved indication (Dec 1972)
- • Approved indication (Jan 1973)
- • Approved indication (Jun 1973)
- • Approved indication (Aug 1973)
- • Approved indication (Oct 1973)
- • Approved indication (Dec 1973)
- • Approved indication (Aug 1974)
- • Approved indication (Sep 1974)
- • Approved indication (Feb 1975)
- • Approved indication (Aug 1976)
- • Approved indication (Nov 1976)
- • Approved indication (Jul 1980)
- • Approved indication (Oct 1984)
- • Approved indication (Dec 2004)
- • Approved indication (Jul 2009)
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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 HYDROCHLORIDE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.