Data updated: Mar 10, 2026
POTASSIUM CHLORIDE
POTASSIUM CHLORIDE
Approved 1971-05-25
88
Indications
--
Phase 3 Trials
54
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1971-05-25
- Routes
- INJECTION, ORAL, Oral
- Dosage Forms
- INJECTABLE, CAPSULE, EXTENDED RELEASE, TABLET, EXTENDED RELEASE, FOR SOLUTION, SOLUTION, Tablet, Extended Release, Tablet
Companies
LUITPOLD INTL MEDICATION ABRAXIS PHARM AMNEAL PHARMS YICHANG HUMANWELL RUBICON RESEARCH QUAGEN Aurobindo Pharma TARO Baxter Fresenius Kabi Merck NOVEL LABS INC WES PHARMA INC GRANULES MACLEODS PHARMS LTD ANDA REPOSITORY COPLEY PHARM ELAN PHARM NESHER PHARMS Eli Lilly B BRAUN STRIDES PHARMA PHARM ASSOC Pfizer GD SEARLE LLC GLENMARK PHARMS LTD PH HEALTH GENUS AMNEAL Apotex NOVITIUM PHARMA TRIS PHARMA INC EPIC PHARMA LLC WATSON LABS PADAGIS US GUANGZHOU NOVAKEN Teva PHARMA SERVE NY TWI PHARMS ASCENT PHARMS INC AJENAT PHARMS RISING NEXUS CHARTWELL MOLECULAR GENUS LIFESCIENCES ZYDUS PHARMS PRINSTON INC SCIEGEN PHARMS ADARE PHARMS INC PHARMOBEDIENT BRECKENRIDGE CHARTWELL RX ESI LEDERLE MILES Lupin SIGMAPHARM LABS LLC
Active Ingredient: POTASSIUM CHLORIDE
Website: ↗
POTASSIUM CHLORIDE Approval History
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What POTASSIUM CHLORIDE Treats
88 FDA approvalsOriginally approved for its first indication in 1971 . Covers 88 distinct patient populations.
- Other (88)
Other
(88 approvals)- • Approved indication (May 1971)
- • Approved indication (Jun 1971)
- • Approved indication (Mar 1972)
- • Approved indication (Feb 1974)
- • Approved indication (Aug 1975)
- • Approved indication (Oct 1977)
- • Approved indication (Mar 1978)
- • Approved indication (Jun 1981)
- • Approved indication (Jun 1986)
- • Approved indication (Feb 1987)
- • Approved indication (Sep 1987)
- • Approved indication (Aug 1994)
- • Approved indication (Apr 1996)
- • Approved indication (Apr 2002)Letter
- • Approved indication (Apr 2002)Letter
- • Approved indication (Aug 2004)
- • Approved indication (Jun 2008)Label
- • Approved indication (May 2011)
- • Approved indication (Feb 2013)
- • Approved indication (Dec 2013)
- • Approved indication (Aug 2014)
- • Approved indication (Dec 2014)Label Letter
- • Approved indication (Aug 2015)Label Letter
- • Approved indication (Nov 2015)
- • Approved indication (Dec 2015)
- • Approved indication (Dec 2015)
- • Approved indication (Jan 2016)
- • Approved indication (Jan 2016)
- • Approved indication (Mar 2016)
- • Approved indication (Mar 2016)
- • Approved indication (Jul 2016)
- • Approved indication (Aug 2016)
- • Approved indication (Aug 2016)
- • Approved indication (Aug 2016)
- • Approved indication (Mar 2017)
- • Approved indication (Jan 2018)
- • Approved indication (Jun 2018)
- • Approved indication (Jul 2018)
- • Approved indication (Aug 2018)Letter
- • Approved indication (Aug 2018)
- • Approved indication (Aug 2018)
- • Approved indication (Nov 2018)
- • Approved indication (Nov 2018)
- • Approved indication (Dec 2018)
- • Approved indication (Jan 2019)
- • Approved indication (Mar 2019)
- • Approved indication (Mar 2019)
- • Approved indication (Apr 2019)
- • Approved indication (Apr 2019)
- • Approved indication (May 2019)
- • Approved indication (May 2019)
- • Approved indication (Jun 2019)
- • Approved indication (Jun 2019)
- • Approved indication (Sep 2019)
- • Approved indication (Mar 2020)
- • Approved indication (May 2020)
- • Approved indication (Aug 2020)
- • Approved indication (Sep 2020)
- • Approved indication (Oct 2020)
- • Approved indication (Dec 2020)
- • Approved indication (Jan 2021)
- • Approved indication (Jan 2021)
- • Approved indication (Feb 2021)
- • Approved indication (Mar 2021)
- • Approved indication (Mar 2021)
- • Approved indication (May 2021)
- • Approved indication (Jan 2022)
- • Approved indication (Jan 2022)
- • Approved indication (Jan 2022)
- • Approved indication (Mar 2022)
- • Approved indication (Jun 2022)
- • Approved indication (Jul 2022)
- • Approved indication (Nov 2022)
- • Approved indication (Dec 2022)
- • Approved indication (Mar 2023)
- • Approved indication (Jun 2023)
- • Approved indication (Jul 2023)
- • Approved indication (Aug 2023)
- • Approved indication (Dec 2023)
- • Approved indication (May 2024)
- • Approved indication (Sep 2024)
- • Approved indication (Oct 2024)
- • Approved indication (Apr 2025) New
- • Approved indication (Jul 2025) New
- • Approved indication (Jul 2025) New
- • Approved indication (Sep 2025) New
- • Approved indication (Nov 2025) New
- • Approved indication (Dec 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.
POTASSIUM CHLORIDE FDA Label Details
ProPOTASSIUM CHLORIDE Patents & Exclusivity
Latest Patent: Mar 2039
Patents (4 active)
US12539314
Expires Mar 7, 2039
Source: FDA Orange Book
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.