Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211190
Company: FRESENIUS KABI USA

Products on ANDA 211190

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	2.5GM/100ML;450MG/100ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211190

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/20/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 211190

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 2.5GM/100ML;450MG/100ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	2.5GM/100ML;450MG/100ML	INJECTABLE;INJECTION	Prescription	No	AP	019631	B BRAUN
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	2.5GM/100ML;450MG/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	016697	BAXTER HLTHCARE
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	DEXTROSE; SODIUM CHLORIDE	2.5GM/100ML;450MG/100ML	INJECTABLE;INJECTION	Prescription	No	AP	211190	FRESENIUS KABI USA