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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212348
Company: FRESENIUS KABI USA

Products on ANDA 212348

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;149MG/100ML;225MG/100ML	INJECTABLE;INJECTION	Prescription	AP	No	No
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;149MG/100ML;225MG/100ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212348

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/30/2021	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212348Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 212348

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 5GM/100ML;149MG/100ML;225MG/100ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;149MG/100ML;225MG/100ML	INJECTABLE;INJECTION	Prescription	No	AP	212348	FRESENIUS KABI USA
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;149MG/100ML;225MG/100ML	INJECTABLE;INJECTION	Prescription	No	AP	212348	FRESENIUS KABI USA
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;149MG/100ML;225MG/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	018365	ICU MEDICAL INC

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 5GM/100ML;149MG/100ML;225MG/100ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;149MG/100ML;225MG/100ML	INJECTABLE;INJECTION	Prescription	No	AP	212348	FRESENIUS KABI USA
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;149MG/100ML;225MG/100ML	INJECTABLE;INJECTION	Prescription	No	AP	212348	FRESENIUS KABI USA
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER	DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	5GM/100ML;149MG/100ML;225MG/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	018365	ICU MEDICAL INC

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