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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209476
Company: FRESENIUS KABI USA

Products on ANDA 209476

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	SODIUM CHLORIDE	3GM/100ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209476

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/13/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 209476

SODIUM CHLORIDE 3% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 3GM/100ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	SODIUM CHLORIDE	3GM/100ML	INJECTABLE;INJECTION	Prescription	No	AP	019635	B BRAUN
SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	SODIUM CHLORIDE	3GM/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	019022	BAXTER HLTHCARE
SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	SODIUM CHLORIDE	3GM/100ML	INJECTABLE;INJECTION	Prescription	No	AP	209476	FRESENIUS KABI USA

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