Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212070
Company: FRESENIUS KABI USA

Products on ANDA 212070

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SODIUM CHLORIDE 14.6%	SODIUM CHLORIDE	50MEQ/20ML (2.5MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	None	No	No
SODIUM CHLORIDE 14.6%	SODIUM CHLORIDE	100MEQ/40ML (2.5MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No
SODIUM CHLORIDE 23.4%	SODIUM CHLORIDE	400MEQ/100ML (4MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212070

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/28/2021	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212070Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 212070

SODIUM CHLORIDE 14.6%

SOLUTION;INTRAVENOUS; 100MEQ/40ML (2.5MEQ/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SODIUM CHLORIDE 14.6%	SODIUM CHLORIDE	100MEQ/40ML (2.5MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	212070	FRESENIUS KABI USA
SODIUM CHLORIDE 14.6%	SODIUM CHLORIDE	100MEQ/40ML (2.5MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	018897	HOSPIRA

SODIUM CHLORIDE 23.4%

SOLUTION;INTRAVENOUS; 400MEQ/100ML (4MEQ/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SODIUM CHLORIDE 23.4%	SODIUM CHLORIDE	400MEQ/100ML (4MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	212070	FRESENIUS KABI USA
SODIUM CHLORIDE 23.4%	SODIUM CHLORIDE	400MEQ/100ML (4MEQ/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	018897	HOSPIRA