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Drugs@FDA: FDA-Approved Drugs

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

Products on NDA 017478

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	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017478

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/17/1976	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY		Label is not available on this site.

Supplements

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) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017478s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017478Orig1s016ltr.pdf
03/09/2015	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
10/21/2011	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017478s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017478s014ltr.pdf
03/03/2004	SUPPL-13	Manufacturing (CMC)-Control	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17478scs013ltr.pdf
01/02/1987	SUPPL-11	Labeling		Label is not available on this site.
08/15/1983	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
07/12/1982	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
07/31/1984	SUPPL-7	Labeling		Label is not available on this site.
07/20/1978	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
11/21/1979	SUPPL-4	Efficacy		Label is not available on this site.
01/16/1979	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.

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

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