Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208122
Company: FRESENIUS KABI USA

Products on ANDA 208122

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	SODIUM CHLORIDE	450MG/100ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208122

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/23/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/10/2022	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
11/30/2020	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
11/05/2020	SUPPL-2	Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 208122

SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 450MG/100ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	SODIUM CHLORIDE	450MG/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	019635	B BRAUN
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	SODIUM CHLORIDE	450MG/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	018016	BAXTER HLTHCARE
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	SODIUM CHLORIDE	450MG/100ML	INJECTABLE;INJECTION	Prescription	No	AP	208122	FRESENIUS KABI USA
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	SODIUM CHLORIDE	450MG/100ML	INJECTABLE;INJECTION	Prescription	No	AP	019759	HOSPIRA
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	SODIUM CHLORIDE	450MG/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	018090	ICU MEDICAL INC