Data updated: Mar 10, 2026
MONTELUKAST SODIUM
MONTELUKAST SODIUM
Approved 2012-08-03
26
Indications
--
Phase 3 Trials
13
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2012-08-03
- Routes
- ORAL
- Dosage Forms
- TABLET, TABLET, CHEWABLE, GRANULE
Companies
Hikma PHARMOBEDIENT AMNEAL PHARMS BRECKENRIDGE ANBISON LAB Aurobindo Pharma AIPING PHARM INC AJANTA PHARMA LTD STRIDES PHARMA INTL PHARMACO SENORES PHARMS Dr. Reddy's RISING NATCO PHARMA CHARTWELL MOLECULAR JUBILANT GENERICS UNICHEM Teva TORRENT PHARMS LTD MACLEODS PHARMS LTD GLENMARK PHARMS LTD Apotex LANNETT CO INC Novartis HETERO LABS LTD V Cipla ACCORD HLTHCARE TORRENT L PERRIGO CO
Active Ingredient: MONTELUKAST SODIUM
Website: ↗
MONTELUKAST SODIUM Approval History
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What MONTELUKAST SODIUM Treats
26 FDA approvalsOriginally approved for its first indication in 2012 . Covers 26 distinct patient populations.
- Other (26)
Other
(26 approvals)- • Approved indication (Aug 2012)Letter
- • Approved indication (Aug 2012)
- • Approved indication (Sep 2012)
- • Approved indication (Sep 2012)
- • Approved indication (Dec 2012)
- • Approved indication (Sep 2014)
- • Approved indication (Sep 2014)
- • Approved indication (Oct 2014)
- • Approved indication (Feb 2015)
- • Approved indication (Mar 2015)
- • Approved indication (May 2015)
- • Approved indication (Jul 2015)
- • Approved indication (Sep 2015)
- • Approved indication (Oct 2015)
- • Approved indication (Nov 2015)
- • Approved indication (Jan 2016)
- • Approved indication (Oct 2016)
- • Approved indication (Apr 2017)Letter
- • Approved indication (Apr 2017)Letter
- • Approved indication (Apr 2017)
- • Approved indication (Jul 2018)
- • Approved indication (Jul 2018)
- • Approved indication (Dec 2018)
- • Approved indication (Feb 2020)
- • Approved indication (Sep 2020)
- • Approved indication (Oct 2020)
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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.
MONTELUKAST SODIUM FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.