FDA NDA · NDA212832

POTASSIUM PHOSPHATES

Sponsor: FRESENIUS KABI USA

APPLICATION

NDA212832

TYPE

NDA

ORIGINAL APPROVAL

2019-11-26

LATEST ACTION

2024-08-30

ROUTE

INTRAVENOUS

DOSAGE FORM

SOLUTION

MARKETING STATUS

Prescription

Products

POTASSIUM PHOSPHATES · ReferencePrescription

POTASSIUM PHOSPHATE, DIBASIC 1.18GM/5ML (236MG/ML), POTASSIUM PHOSPHATE, MONOBASIC 1.12GM/5ML (224MG/ML) · SOLUTION · INTRAVENOUS

POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE · ReferencePrescription

POTASSIUM PHOSPHATE, DIBASIC 1.18GM/100ML (11.8MG/ML), POTASSIUM PHOSPHATE, MONOBASIC 1.12GM/100ML (11.2MG/ML) · SOLUTION · INTRAVENOUS

POTASSIUM PHOSPHATES · ReferencePrescription

POTASSIUM PHOSPHATE, DIBASIC 3.54GM/15ML (236MG/ML), POTASSIUM PHOSPHATE, MONOBASIC 3.36GM/15ML (224MG/ML) · SOLUTION · INTRAVENOUS

POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE · ReferencePrescription

POTASSIUM PHOSPHATE, DIBASIC 1.18GM/250ML (4.72MG/ML), POTASSIUM PHOSPHATE, MONOBASIC 1.12GM/250ML (4.48MG/ML) · SOLUTION · INTRAVENOUS

POTASSIUM PHOSPHATES · ReferencePrescription

POTASSIUM PHOSPHATE, DIBASIC 11.8GM/50ML (236MG/ML), POTASSIUM PHOSPHATE, MONOBASIC 11.2GM/50ML (224MG/ML) · SOLUTION · INTRAVENOUS

2024-08-30Manufacturing (CMC) · Supplement 2 — Label ↗AP

2019-11-26Type 5 - New Formulation or New Manufacturer · Original · priority — Label ↗AP

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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