Data updated: Mar 10, 2026
LOSARTAN POTASSIUM
LOSARTAN POTASSIUM
Approved 2010-04-06
14
Indications
--
Phase 3 Trials
15
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2010-04-06
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
Hikma Lupin ALEMBIC PHARMS LTD GRANULES STRIDES PHARMA IPCA LABS LTD HETERO LABS LTD V HISUN PHARM HANGZHOU Apotex Viatris GRAVITI PHARMS MSN PRINSTON INC MACLEODS PHARMS LTD CHARTWELL RX WATSON LABS Teva ZYDUS PHARMS USA INC AIPING PHARM INC JUBILANT CADISTA UNICHEM Aurobindo Pharma TORRENT PHARMS MICRO LABS
Active Ingredient: LOSARTAN POTASSIUM
Website: ↗
LOSARTAN POTASSIUM Approval History
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What LOSARTAN POTASSIUM Treats
14 FDA approvalsOriginally approved for its first indication in 2010 . Covers 14 distinct patient populations.
- Other (14)
Other
(14 approvals)- • Approved indication (Apr 2010)Letter
- • Approved indication (Oct 2010)
- • Approved indication (Jun 2011)
- • Approved indication (May 2012)
- • Approved indication (Sep 2012)
- • Approved indication (Sep 2012)
- • Approved indication (Aug 2013)
- • Approved indication (Aug 2015)Letter
- • Approved indication (Oct 2015)Letter
- • Approved indication (Apr 2019)
- • Approved indication (Feb 2023)
- • Approved indication (Aug 2023)
- • Approved indication (Jun 2024)
- • Approved indication (Sep 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.
LOSARTAN POTASSIUM FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.