Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211211
Company: FRESENIUS KABI USA

Products on ANDA 211211

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	DEXTROSE; SODIUM CHLORIDE	5GM/100ML;900MG/100ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211211

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/14/2020	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 211211

DEXTROSE 5% AND SODIUM CHLORIDE 0.9%

INJECTABLE;INJECTION; 5GM/100ML;900MG/100ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	DEXTROSE; SODIUM CHLORIDE	5GM/100ML;900MG/100ML	INJECTABLE;INJECTION	Prescription	No	AP	211211	FRESENIUS KABI USA
DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	5GM/100ML;900MG/100ML	INJECTABLE;INJECTION	Prescription	No	AP	019631	B BRAUN
DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	5GM/100ML;900MG/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	017585	ICU MEDICAL INC
DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	5GM/100ML;900MG/100ML	INJECTABLE;INJECTION	Prescription	No	AP	016678	BAXTER HLTHCARE