Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016694
Company: BAXTER HLTHCARE

Products on NDA 16694

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 016694

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/05/2019	SUPPL-121	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016673s149,016694s121lbl.pdf
12/22/2014	SUPPL-119	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017521s068lbl.pdf