Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017478
Company: LANTHEUS MEDCL

Products on NDA 17478

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GALLIUM CITRATE GA 67	GALLIUM CITRATE GA-67	2mCi/ML	INJECTABLE;INJECTION	Prescription	BS	No	No

Labels for NDA 017478

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/06/2018	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017478s016lbl.pdf
10/21/2011	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017478s014lbl.pdf