Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217263
Company: AM REGENT

Products on ANDA 217263

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217263

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/08/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217263

DEXTROSE 5%

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%	DEXTROSE	50MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	217263	AM REGENT
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	ICU MEDICAL INC