Drugs@FDA: FDA Approved Drug Products

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

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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