TheraRadar
Data updated: May 26, 2026

SODIUM PHOSPHATES (sodium phosphate, dibasic, heptahydrate)

Other Approved 2022-03-30

SODIUM PHOSPHATES is indicated for the treatment of Hypophosphatemia.

Source: FDA Label • Fresenius Kabi
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
3
Indications
--
Phase 3 Trials
4
Years on Market

Details

Status
Prescription
First Approved
2022-03-30
Routes
INTRAVENOUS
Dosage Forms
SOLUTION

Companies

Fresenius Kabi AM REGENT CAPLIN
Active Ingredient: SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE , SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE

SODIUM PHOSPHATES Approval History

2023
2024
2025
2026
Original
New Indication
New Form
Label Update
9 FDA actions from 2022 to 2026
Feb 2026 ORIGINAL
Update
Jun 2024 ORIGINAL
Update
Mar 2022 ORIGINAL
Update
FDA Letter

What SODIUM PHOSPHATES Treats

1 indications

SODIUM PHOSPHATES is approved for 1 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypophosphatemia
Source: FDA Label

SODIUM PHOSPHATES Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

2

Same indication, different mechanism — what else might this patient receive?

POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE
AMNEAL
2019 1 indic.
POTASSIUM PHOSPHATES
Pfizer
2019 1 indic.

Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to SODIUM PHOSPHATES

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

POTASSIUM PHOSPHATES
POTASSIUM PHOSPHATE, DIBASIC
1 shared
Pfizer
Shared indications:
Hypophosphatemia
POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE
POTASSIUM PHOSPHATE, DIBASIC
1 shared
AMNEAL
Shared indications:
Hypophosphatemia
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Active Pipeline

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Key Completed Trials

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Trial Timeline

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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.

SODIUM PHOSPHATES FDA Label Details

Indications & Usage

SODIUM PHOSPHATES is indicated for the treatment of Hypophosphatemia.

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Data Sources

FDA Approval: ANDA209997 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.