Data updated: Mar 10, 2026
IBUPROFEN
IBUPROFEN
Approved 1985-07-24
117
Indications
--
Phase 3 Trials
40
Years on Market
Details
- Status
- Over-the-counter
- First Approved
- 1985-07-24
- Routes
- ORAL
- Dosage Forms
- TABLET, CAPSULE, SUSPENSION, SUSPENSION/DROPS, TABLET, CHEWABLE
Companies
AVEMA PHARMA AMNEAL PHARMS NY BIONPHARMA STRIDES PHARMA SUPERPHARM P AND L DEV LLC Sun Pharma PLIVA PUREPAC PHARM PH HEALTH LNK PERRIGO Dr. Reddy's L PERRIGO CO NORTHSTAR HLTHCARE GRANULES ALKEM LABS LTD WATSON LABS STRIDES PHARMA INTL IVAX SUB TEVA PHARMS OHM LEINER CONTRACT PHARMACAL Novartis RISING PHARMOBEDIENT MCNEIL MARKSANS PHARMA SHANDONG XINHUA Aurobindo Pharma SUN PHARMA CANADA LEDERLE MERRO PHARM HALSEY ANI PHARMS Teva GUARDIAN DRUG ANNORA PHARMA PATHEON SOFTGELS ABBOTT P AND L PADAGIS US ONESOURCE SPECIALTY HUMANWELL PURACAP YICHANG HUMANWELL OHM LABS ADAPTIS PERRIGO R AND D AMNEAL PHARMS PAI HOLDINGS PHARM SUNSHINE ASCENT PHARMS INC PAR PHARM TRIS PHARMA INC SOFGEN PHARMS ULTRATAB LABS INC GRANULES INDIA ARISE J AND J CONSUMER INC
Active Ingredient: IBUPROFEN
Website: ↗
IBUPROFEN Approval History
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What IBUPROFEN Treats
117 FDA approvalsOriginally approved for its first indication in 1985 . Covers 117 distinct patient populations.
- Other (117)
Other
(117 approvals)- • Approved indication (Jul 1985)
- • Approved indication (Aug 1985)
- • Approved indication (Aug 1985)
- • Approved indication (Sep 1985)
- • Approved indication (Oct 1985)
- • Approved indication (Dec 1985)
- • Approved indication (Dec 1985)
- • Approved indication (Mar 1986)
- • Approved indication (Apr 1986)
- • Approved indication (Jun 1986)
- • Approved indication (Jun 1986)
- • Approved indication (Jul 1986)
- • Approved indication (Jul 1986)
- • Approved indication (Sep 1986)
- • Approved indication (Sep 1986)
- • Approved indication (Sep 1986)
- • Approved indication (Oct 1986)
- • Approved indication (Oct 1986)
- • Approved indication (Oct 1986)
- • Approved indication (Nov 1986)
- • Approved indication (Dec 1986)
- • Approved indication (Jan 1987)
- • Approved indication (Feb 1987)
- • Approved indication (Feb 1987)
- • Approved indication (Apr 1987)
- • Approved indication (May 1987)
- • Approved indication (Jun 1987)
- • Approved indication (Jul 1987)
- • Approved indication (Sep 1987)
- • Approved indication (Sep 1987)
- • Approved indication (Oct 1987)
- • Approved indication (Oct 1987)
- • Approved indication (Nov 1987)
- • Approved indication (Dec 1987)
- • Approved indication (Dec 1987)
- • Approved indication (Dec 1987)
- • Approved indication (Jan 1988)
- • Approved indication (Feb 1988)
- • Approved indication (Feb 1988)
- • Approved indication (Feb 1988)
- • Approved indication (May 1988)
- • Approved indication (May 1988)
- • Approved indication (Jul 1988)
- • Approved indication (Jan 1989)
- • Approved indication (Dec 1991)
- • Approved indication (May 1992)
- • Approved indication (Jun 1992)
- • Approved indication (Feb 1994)
- • Approved indication (Mar 1994)
- • Approved indication (Dec 1995)
- • Approved indication (Mar 1998)Label
- • Approved indication (Jul 1998)Letter
- • Approved indication (Jul 1998)Label Letter
- • Approved indication (Jul 1998)
- • Approved indication (Dec 1998)Label Letter
- • Approved indication (Mar 1999)Letter
- • Approved indication (Apr 1999)Letter
- • Approved indication (Oct 2001)
- • Approved indication (Nov 2001)Letter
- • Approved indication (Nov 2001)Letter
- • Approved indication (Dec 2001)Label Letter
- • Approved indication (Mar 2002)Letter
- • Approved indication (Nov 2003)
- • Approved indication (Jan 2004)Letter
- • Approved indication (Jun 2004)
- • Approved indication (Sep 2004)
- • Approved indication (Jun 2005)
- • Approved indication (Jul 2005)
- • Approved indication (Jun 2007)
- • Approved indication (Sep 2007)
- • Approved indication (Feb 2009)
- • Approved indication (Mar 2009)
- • Approved indication (Jun 2009)
- • Approved indication (Jul 2009)
- • Approved indication (Aug 2009)
- • Approved indication (Dec 2010)
- • Approved indication (Dec 2010)
- • Approved indication (Feb 2011)
- • Approved indication (Feb 2011)
- • Approved indication (Mar 2011)
- • Approved indication (Apr 2011)
- • Approved indication (Aug 2011)
- • Approved indication (Dec 2011)
- • Approved indication (Mar 2014)
- • Approved indication (Sep 2015)
- • Approved indication (Jun 2016)
- • Approved indication (Sep 2016)
- • Approved indication (Oct 2016)
- • Approved indication (Nov 2016)
- • Approved indication (Nov 2016)
- • Approved indication (May 2017)
- • Approved indication (May 2017)
- • Approved indication (Jun 2017)
- • Approved indication (Jun 2017)
- • Approved indication (Nov 2017)
- • Approved indication (Dec 2017)
- • Approved indication (Feb 2018)
- • Approved indication (Mar 2018)
- • Approved indication (Apr 2018)
- • Approved indication (Jun 2018)
- • Approved indication (Aug 2018)
- • Approved indication (Sep 2018)
- • Approved indication (Sep 2018)
- • Approved indication (Nov 2018)
- • Approved indication (Jan 2020)
- • Approved indication (May 2020)
- • Approved indication (Oct 2020)
- • Approved indication (Feb 2021)
- • Approved indication (Sep 2021)
- • Approved indication (Mar 2022)
- • Approved indication (May 2022)
- • Approved indication (Jun 2022)Letter
- • Approved indication (Aug 2023)
- • Approved indication (Sep 2023)
- • Approved indication (Feb 2024)
- • Approved indication (Apr 2024)
- • Approved indication (Nov 2024)
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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.
IBUPROFEN FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.