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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017284
Company: LANTHEUS MEDCL

Products on NDA 017284

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
XENON XE 133	XENON XE-133	10mCi/VIAL	GAS;INHALATION	Prescription	None	No	No
XENON XE 133	XENON XE-133	20mCi/VIAL	GAS;INHALATION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017284

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/10/1974	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/10/2016	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
09/14/2011	SUPPL-12	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017284s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017284s012ltr.pdf
10/27/2003	SUPPL-9	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17284slr009LTR.pdf
03/27/1998	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
07/11/1991	SUPPL-7	Manufacturing (CMC)-Packaging		Label is not available on this site.
02/24/1989	SUPPL-6	Manufacturing (CMC)-Packaging		Label is not available on this site.
05/04/1987	SUPPL-5	Labeling		Label is not available on this site.
05/21/1982	SUPPL-4	Labeling		Label is not available on this site.
07/20/1981	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
09/29/1978	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
04/07/1978	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 017284

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/14/2011	SUPPL-12	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017284s012lbl.pdf

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