Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212248
Company: FRESENIUS KABI USA

Products on ANDA 212248

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SODIUM CHLORIDE 23.4%	SODIUM CHLORIDE	234MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212248

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/2021/212248Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 212248

SODIUM CHLORIDE 23.4%

INJECTABLE;INJECTION; 234MG/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	234MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	212248	FRESENIUS KABI USA
SODIUM CHLORIDE 23.4%	SODIUM CHLORIDE	234MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	217796	FRESENIUS KABI USA