Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209448
Company: FRESENIUS KABI USA

Products on ANDA 209448

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEXTROSE 10% IN PLASTIC CONTAINER	DEXTROSE	10GM/100ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209448

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/16/2018	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209448Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/28/2023	SUPPL-7	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 209448

DEXTROSE 10% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 10GM/100ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEXTROSE 10% IN PLASTIC CONTAINER	DEXTROSE	10GM/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	019626	B BRAUN
DEXTROSE 10% IN PLASTIC CONTAINER	DEXTROSE	10GM/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	016694	BAXTER HLTHCARE
DEXTROSE 10% IN PLASTIC CONTAINER	DEXTROSE	10GM/100ML	INJECTABLE;INJECTION	Prescription	No	AP	209448	FRESENIUS KABI USA
DEXTROSE 10% IN PLASTIC CONTAINER	DEXTROSE	10GM/100ML	INJECTABLE;INJECTION	Prescription	Yes	AP	018080	ICU MEDICAL INC