Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019445
Company: HOSPIRA

Products on NDA 19445

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEXTROSE 25%	DEXTROSE	250MG/ML	INJECTABLE;INJECTION	Prescription	None	Yes	Yes
DEXTROSE 50%	DEXTROSE	500MG/ML	INJECTABLE;INJECTION	Prescription	AP	Yes	No

Labels for NDA 019445

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/25/2025	SUPPL-49	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019445s043s049lbl.pdf
07/25/2025	SUPPL-43	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019445s043s049lbl.pdf