Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 017243
Company: CURIUM

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ULTRA-TECHNEKOW FM	TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR	0.25-3 CI/GENERATOR	SOLUTION;INTRAVENOUS	Discontinued	None	No	No
ULTRA-TECHNEKOW FM	TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR	1-19 CI/GENERATOR	SOLUTION;INTRAVENOUS	Prescription	None	Yes	Yes

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/04/2015	SUPPL-46	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017243Orig1s046lbl.pdf
02/18/2014	SUPPL-43	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017243s043lbl.pdf
12/20/2013	SUPPL-44	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017243Orig1s044lbl.pdf
10/15/2004	SUPPL-25	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/17243s025lbl.pdf