FDA.reportPublic FDA data

Application 017284

Type
NDA
Sponsor
LANTHEUS MEDCL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001XENON XE 133XENON XE-133GAS;INHALATION10mCi/VIALNoNo
002XENON XE 133XENON XE-133GAS;INHALATION20mCi/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
11994-127XenonXenon XE-133Lantheus Medical Imaging, Inc.NDACurrent
11994-127XenonXenon XE-133Lantheus Medical Imaging, Inc.NDACurrent
11994-127XenonXenon XE-133Lantheus Medical Imaging, Inc.NDACurrent
11994-128XenonXenon XE-133Lantheus Medical Imaging, Inc.NDACurrent
11994-128XenonXenon XE-133Lantheus Medical Imaging, Inc.NDACurrent
11994-128XenonXenon XE-133Lantheus Medical Imaging, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
13106SUPPL2011-09-16
10974SUPPL2011-09-16
13105SUPPL2003-10-29