FDA.reportPublic FDA data

Application 017837

Type
BLA
Sponsor
ISO TEX

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
017837Megatopeiodinated I-131 albumin351(a)Disc2026-08-01

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MegatopeIODINATED I-131 ALBUMINIso-Tex Diagnostics, Inc.62ca4278-8cc9-46b7-8f3c-303ce6a9c1552023-09-01Warnings, Adverse reactionsExact identifier
application number: BLA017837
ndc (product): 50914-7731
VolumexIODINATED I-131 ALBUMINIso-Tex Diagnostics, Inc.812240e4-fc28-46c2-92f3-1ba4e029645a2022-11-21Warnings, Adverse reactionsExact identifier
application number: BLA017837
ndc (product): 50914-7720

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

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.NDACurrent
50914-7720VolumexIodinated I-131 AlbuminIso-Tex Diagnostics, Inc.BLACurrent
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