Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018080
Company: OTSUKA ICU MEDCL

Products on NDA 18080

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	Yes	Yes

Labels for NDA 018080

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/09/2025	SUPPL-122	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/016367s231,018080s122lbl.pdf