Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213688
Company: FRESENIUS KABI USA

Products on ANDA 213688

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	900MG/100ML	SOLUTION;IRRIGATION	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213688

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/24/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 213688

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

SOLUTION;IRRIGATION; 900MG/100ML
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	900MG/100ML	SOLUTION;IRRIGATION	Prescription	Yes	AT	016733	B BRAUN
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	900MG/100ML	SOLUTION;IRRIGATION	Prescription	No	AT	017427	BAXTER HLTHCARE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	900MG/100ML	SOLUTION;IRRIGATION	Prescription	No	AT	017867	BAXTER HLTHCARE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	900MG/100ML	SOLUTION;IRRIGATION	Prescription	No	AT	213688	FRESENIUS KABI USA
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	900MG/100ML	SOLUTION;IRRIGATION	Prescription	Yes	AT	017514	ICU MEDICAL INC
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	900MG/100ML	SOLUTION;IRRIGATION	Prescription	No	AT	018314	ICU MEDICAL INC