CALCIUM ACETATE
Details
- Status
- Prescription
- First Approved
- 2008-01-30
- Routes
- ORAL
- Dosage Forms
- CAPSULE, TABLET
Companies
CALCIUM ACETATE Approval History
What CALCIUM ACETATE Treats
14 FDA approvalsOriginally approved for its first indication in 2008 . Covers 14 distinct patient populations.
- Other (14)
Other
(14 approvals)- • Approved indication (Jan 2008)Letter
- • Approved indication (Feb 2008)Letter
- • Approved indication (Apr 2011)
- • Approved indication (Jun 2012)
- • Approved indication (Feb 2013)
- • Approved indication (Feb 2013)
- • Approved indication (Oct 2014)
- • Approved indication (Jan 2015)
- • Approved indication (Jun 2015)
- • Approved indication (Jul 2015)Letter
- • Approved indication (Oct 2015)
- • Approved indication (Jul 2016)
- • Approved indication (Feb 2020)
- • Approved indication (Mar 2023)
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
CALCIUM ACETATE FDA Label Details
ProIndications & Usage
Calcium acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD). Calcium acetate is a phosphate binder indicated for the reduction of serum phosphorus in patients with end stage renal disease.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.