Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018251
Company: OTSUKA ICU MEDCL

Products on NDA 18251

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RINGER'S IN PLASTIC CONTAINER	CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE	33MG/100ML;30MG/100ML;860MG/100ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Labels for NDA 018251

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/24/2026	SUPPL-97	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/018251s097lbl.pdf