Data updated: Mar 10, 2026
NAPROXEN
NAPROXEN
Approved 1992-10-30
31
Indications
--
Phase 3 Trials
33
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1992-10-30
- Routes
- ORAL
- Dosage Forms
- TABLET, TABLET, DELAYED RELEASE, SUSPENSION
Companies
L PERRIGO CO NUVO PHARMS INC PLIVA AMNEAL Teva ZYDUS PHARMS USA HETERO LABS LTD III Hikma ROXANE INVAGEN PHARMS NOVITIUM PHARMA WATSON LABS FOSUN PHARMA PHARMOBEDIENT GRANULES Aurobindo Pharma SCIEGEN PHARMS CHARTWELL MOLECULES GLENMARK PHARMS LTD ADAPTIS IVAX SUB TEVA PHARMS AMNEAL PHARMS NY TP ANDA HOLDINGS DAVA PHARMS INC HAMILTON PHARMS WATSON LABS TEVA PUREPAC PHARM
Active Ingredient: NAPROXEN
Website: ↗
NAPROXEN Approval History
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What NAPROXEN Treats
31 FDA approvalsOriginally approved for its first indication in 1992 . Covers 31 distinct patient populations.
- Other (31)
Other
(31 approvals)- • Approved indication (Oct 1992)
- • Approved indication (Dec 1993)
- • Approved indication (Feb 1994)
- • Approved indication (Mar 1994)
- • Approved indication (Feb 1995)
- • Approved indication (Feb 1995)
- • Approved indication (Apr 1995)
- • Approved indication (May 1995)
- • Approved indication (Apr 1996)
- • Approved indication (Jun 1996)
- • Approved indication (Feb 1998)
- • Approved indication (Feb 1998)Label Letter
- • Approved indication (Jun 1998)Letter
- • Approved indication (May 1999)Letter
- • Approved indication (Apr 2001)Label Letter
- • Approved indication (Dec 2001)
- • Approved indication (Jan 2004)
- • Approved indication (Apr 2005)
- • Approved indication (Mar 2007)
- • Approved indication (Jun 2007)
- • Approved indication (Feb 2011)
- • Approved indication (Aug 2011)
- • Approved indication (Sep 2011)
- • Approved indication (Nov 2011)
- • Approved indication (Feb 2020)
- • Approved indication (Jul 2020)
- • Approved indication (Mar 2021)
- • Approved indication (Jun 2022)
- • Approved indication (May 2023)
- • Approved indication (Jun 2024)
- • Approved indication (Oct 2025) New
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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.
NAPROXEN FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.