Data updated: Mar 10, 2026
SEVELAMER CARBONATE
SEVELAMER CARBONATE
Approved 2017-06-13
26
Indications
--
Phase 3 Trials
8
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2017-06-13
- Routes
- ORAL
- Dosage Forms
- TABLET, FOR SUSPENSION
Companies
EPIC PHARMA LLC SHANDONG XINHUA RISING ZYDUS PHARMS CHARTWELL RX IMPAX LABS INC INVAGEN PHARMS Aurobindo Pharma NAVINTA LLC Dr. Reddy's MACLEODS PHARMS LTD BIONPHARMA IMPAX STRIDES PHARMA INTL MICRO LABS ARTHUR GRP Lupin AMNEAL PHARMS CO TORRENT STRIDES PHARMA
Active Ingredient: SEVELAMER CARBONATE
Website: ↗
SEVELAMER CARBONATE Approval History
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What SEVELAMER CARBONATE Treats
26 FDA approvalsOriginally approved for its first indication in 2017 . Covers 26 distinct patient populations.
- Other (26)
Other
(26 approvals)- • Approved indication (Jun 2017)Label Letter
- • Approved indication (Jul 2017)Letter
- • Approved indication (Sep 2017)
- • Approved indication (Oct 2017)
- • Approved indication (Oct 2017)
- • Approved indication (Nov 2017)
- • Approved indication (Mar 2018)
- • Approved indication (Oct 2018)
- • Approved indication (Nov 2018)
- • Approved indication (Apr 2020)
- • Approved indication (Aug 2020)
- • Approved indication (Aug 2020)
- • Approved indication (Nov 2020)
- • Approved indication (Jan 2021)
- • Approved indication (May 2021)
- • Approved indication (Dec 2021)
- • Approved indication (Feb 2022)
- • Approved indication (Mar 2023)
- • Approved indication (Apr 2023)
- • Approved indication (Sep 2023)
- • Approved indication (Apr 2024)
- • Approved indication (May 2024)
- • Approved indication (Jul 2024)
- • Approved indication (Oct 2024)
- • Approved indication (Feb 2025)
- • Approved indication (Oct 2025) New
🔬
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.
SEVELAMER CARBONATE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.