FDA.reportPublic FDA data

Application 204677

Type
NDA
Sponsor
LIFE MOLECULAR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEURACEQFLORBETABEN F-18SOLUTION;INTRAVENOUS30ML (1.4-135mCi/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
54828-001Neuraceqflorbetaben F 18Life Molecular Imaging, SANDACurrent
54828-001Neuraceqflorbetaben F 18Life Molecular Imaging, SANDACurrent
54828-001Neuraceqflorbetaben F 18Life Molecular Imaging, SANDACurrent
54828-001Neuraceqflorbetaben F 18Life Molecular Imaging, LtdNDACurrent
54828-001Neuraceqflorbetaben F 18Life Molecular Imaging, LtdNDACurrent
54828-001Neuraceqflorbetaben F 18Life Molecular Imaging, LtdNDACurrent
54828-001Neuraceqflorbetaben F 18Life Molecular Imaging, SANDACurrent
54828-001Neuraceqflorbetaben F 18Piramal Imaging, SANDACurrent
54828-001Neuraceqflorbetaben F 18Life Molecular Imaging, SANDACurrent
54828-001Neuraceqflorbetaben F 18Life Molecular Imaging, SANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82657SUPPL 2025-06-24
82656SUPPL 2025-06-24
82651SUPPL 2025-06-24
82650SUPPL 2025-06-24
76028SUPPL 2023-11-02
76027SUPPL 2023-11-02
71767SUPPL2022-08-10
71752SUPPL2022-08-09
61572SUPPL2020-01-14
61567SUPPL2020-01-14
48772SUPPL2017-06-19
48757SUPPL2017-06-19
45494SUPPL2016-10-06
45474SUPPL2016-10-04
45166SUPPL2016-08-25
45057SUPPL2016-08-25
43473ORIG2014-04-14
24479ORIG2014-04-14
19586SUPPL2014-04-08
32580SUPPL2014-04-04
32579ORIG2014-03-21
40411ORIG2014-03-20