Data updated: Mar 10, 2026
INDOMETHACIN
INDOMETHACIN
Approved 1984-04-20
43
Indications
--
Phase 3 Trials
41
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1984-04-20
- Routes
- ORAL, RECTAL, INJECTION
- Dosage Forms
- CAPSULE, SUPPOSITORY, CAPSULE, EXTENDED RELEASE, SUSPENSION, INJECTABLE
Companies
PARKE DAVIS CHARTWELL MOLECULES HETERO LABS LTD III ANNORA PHARMA DURAMED PHARMS BARR Novartis WATSON LABS CHARTWELL RX WATSON LABS INC ZYDUS LIFESCIENCES SUPERPHARM Teva INWOOD LABS GLENMARK PHARMS LTD CYCLE HALSEY Sun Pharma ANI PHARMS NOVAST LABS PIONEER PHARMS Hikma ABLE AMNEAL PHARMS MUTUAL PHARM JUBILANT GENERICS AMNEAL RISING AVANTHI INC HERITAGE Aurobindo Pharma COSETTE IVAX SUB TEVA PHARMS Viatris ZYDUS PHARMS HERITAGE PHARMA NOVITIUM PHARMA Fresenius Kabi
Active Ingredient: INDOMETHACIN
Website: ↗
INDOMETHACIN Approval History
Loading approval history...
What INDOMETHACIN Treats
43 FDA approvalsOriginally approved for its first indication in 1984 . Covers 43 distinct patient populations.
- Other (43)
Other
(43 approvals)- • Approved indication (Apr 1984)
- • Approved indication (May 1984)
- • Approved indication (May 1984)
- • Approved indication (Aug 1984)
- • Approved indication (Sep 1985)
- • Approved indication (Oct 1985)
- • Approved indication (Feb 1986)
- • Approved indication (Mar 1986)
- • Approved indication (Oct 1986)
- • Approved indication (Oct 1986)
- • Approved indication (Feb 1987)
- • Approved indication (Mar 1987)
- • Approved indication (Apr 1987)
- • Approved indication (May 1987)
- • Approved indication (Apr 1988)
- • Approved indication (Mar 1989)
- • Approved indication (Jul 1991)
- • Approved indication (Aug 1992)
- • Approved indication (May 1998)Letter
- • Approved indication (Feb 2002)Letter
- • Approved indication (Dec 2003)
- • Approved indication (Mar 2009)
- • Approved indication (Mar 2010)Label Letter
- • Approved indication (Nov 2010)
- • Approved indication (Nov 2010)
- • Approved indication (Dec 2010)
- • Approved indication (Dec 2010)
- • Approved indication (Apr 2011)
- • Approved indication (Sep 2012)
- • Approved indication (Mar 2013)
- • Approved indication (Dec 2013)
- • Approved indication (Mar 2014)
- • Approved indication (Oct 2015)
- • Approved indication (Dec 2016)
- • Approved indication (May 2017)
- • Approved indication (Jun 2017)
- • Approved indication (Aug 2017)
- • Approved indication (Sep 2017)Letter
- • Approved indication (Aug 2023)
- • Approved indication (Jan 2024)
- • Approved indication (Nov 2024)
- • Approved indication (Feb 2025)
- • Approved indication (Jul 2025) New
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
Loading...
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.
INDOMETHACIN FDA Label Details
ProWant competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.