Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019981
Company: CURIUM

Products on NDA 19981

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ULTRATAG	TECHNETIUM TC-99M RED BLOOD CELL KIT	N/A	INJECTABLE;INJECTION	Prescription	None	Yes	Yes

Labels for NDA 019981

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/27/2025	SUPPL-11	Manufacturing (CMC)-Manufacturing Process	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/019981Orig1s011lbl.pdf