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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207449
Company: FRESENIUS KABI USA

Products on ANDA 207449

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE	50MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207449

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/21/2016	ORIG-1	Approval		STANDARD	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207449Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207449Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/20/2022	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
11/20/2020	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
06/26/2018	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 207449

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/21/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207449Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 207449

DEXTROSE 5% IN PLASTIC CONTAINER

INJECTABLE;INJECTION; 50MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE	50MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	016730	B BRAUN
DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE	50MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	016673	BAXTER HLTHCARE
DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE	50MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	020179	BAXTER HLTHCARE
DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE	50MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	207449	FRESENIUS KABI USA
DEXTROSE 5% IN PLASTIC CONTAINER	DEXTROSE	50MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	016367	OTSUKA ICU MEDCL

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