Potassium Phosphates, Potassium Phosphates In 0.9% Sodium Chloride

NDA 212832, held by Fresenius Kabi USA. Potassium Phosphate, Dibasic; Potassium Phosphate, Monobasic.

As of Nov 13, 2026, NDA 212832 (Potassium Phosphates, Potassium Phosphates In 0.9% Sodium Chloride), held by Fresenius Kabi USA, was first approved by FDA on Nov 26, 2019, with 1 approved supplement and 0 published complete response letters.

First approved: Nov 26, 2019
Review: Priority
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Potassium Phosphates in Sodium Chloride Injection is indicated as a source of phosphorus to correct hypophosphatemia in adults and pediatric patients who weigh 40 kg or greater when oral or enteral replacement is not possible, insufficient, or contraindicated.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Nov 26, 2019	Original applicationNew formulation or manufacturer · Priority review	Approved	Review Label Letter

Products

5 strengths and forms

Product	Active ingredient	Marketing
Potassium Phosphates1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) · solution;intravenous	Potassium Phosphate, Dibasic; Potassium Phosphate, Monobasic	RxReference drug
Potassium Phosphates3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) · solution;intravenous	Potassium Phosphate, Dibasic; Potassium Phosphate, Monobasic	RxReference drug
Potassium Phosphates11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) · solution;intravenous	Potassium Phosphate, Dibasic; Potassium Phosphate, Monobasic	RxReference drug
Potassium Phosphates In 0.9% Sodium Chloride1.18GM/100ML (11.8MG/ML);1.12GM/100ML (11.2MG/ML) · solution;intravenous	Potassium Phosphate, Dibasic; Potassium Phosphate, Monobasic	RxReference drug
Potassium Phosphates In 0.9% Sodium Chloride1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML) · solution;intravenous	Potassium Phosphate, Dibasic; Potassium Phosphate, Monobasic	RxReference drug

All 2 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Aug 30, 2024	Supplement 2Manufacturing	Approved	Label Letter
Nov 26, 2019	Original applicationNew formulation or manufacturer · Priority review	Approved	Review Label Letter

Identifiers

Application: NDA 212832
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi USA

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters