Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018563
Company: OTSUKA ICU MEDCL

Products on NDA 18563

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEXTROSE 50% IN PLASTIC CONTAINER	DEXTROSE	50GM/100ML	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes

Labels for NDA 018563

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/14/2018	SUPPL-60	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018561s060,018562s059,018563s060,018564s062,019345s047lbl.pdf
02/22/2016	SUPPL-57	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018561s057,018562s056,018563s057,018564s059,019345s044lbl.pdf