Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217459
Company: HOSPIRA

Products on ANDA 217459

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
POTASSIUM PHOSPHATES	POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC	3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217459

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/11/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217459

POTASSIUM PHOSPHATES

SOLUTION;INTRAVENOUS; 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
POTASSIUM PHOSPHATES	POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC	3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216274	AM REGENT
POTASSIUM PHOSPHATES	POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC	3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	216344	AMNEAL
POTASSIUM PHOSPHATES	POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC	3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	220373	CAPLIN
POTASSIUM PHOSPHATES	POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC	3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	217892	CIPLA
POTASSIUM PHOSPHATES	POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC	3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	212832	FRESENIUS KABI USA
POTASSIUM PHOSPHATES	POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC	3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	217459	HOSPIRA
POTASSIUM PHOSPHATES	POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC	3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	217726	SOMERSET THERAPS LLC