FDA.reportPublic FDA data

Application 017837

Type
BLA
Sponsor
ISO TEX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MEGATOPEALBUMIN IODINATED I-131 SERUMINJECTABLE;INJECTION0.5mCi/VIALNoNo
002MEGATOPEALBUMIN IODINATED I-131 SERUMINJECTABLE;INJECTION1mCi/VIALNoNo
003MEGATOPEALBUMIN IODINATED I-131 SERUMINJECTABLE;INJECTION2mCi/VIALNoNo
004MEGATOPEALBUMIN IODINATED I-131 SERUMINJECTABLE;INJECTION5uCi/AMPNoNo
005MEGATOPEALBUMIN IODINATED I-131 SERUMINJECTABLE;INJECTION20uCi/AMPNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50914-7720VolumexIodinated I-131 AlbuminIso-Tex Diagnostics, Inc.BLACurrent
50914-7720VolumexIodinated I-131 AlbuminIso-Tex Diagnostics, Inc.BLACurrent
50914-7720VolumexIodinated I-131 AlbuminIso-Tex Diagnostics, Inc.NDACurrent
50914-7720VolumexIodinated I-131 AlbuminIso-Tex Diagnostics, Inc.NDACurrent
50914-7731MegatopeIodinated I-131 AlbuminIso-Tex Diagnostics, Inc.BLACurrent
50914-7731MegatopeIodinated I-131 AlbuminIso-Tex Diagnostics, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75311SUPPL 2023-08-29
75299SUPPL 2023-08-28
66381APPL2020-03-23