FDA.reportPublic FDA data

Application 017836

Type
BLA
Sponsor
ISO TEX

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
017836Jeanatopeiodinated I-125 albumin351(a)Disc2026-08-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001JEANATOPEALBUMIN IODINATED I-125 SERUMINJECTABLE;INJECTION500uCi/0.5MLNoNo
002JEANATOPEALBUMIN IODINATED I-125 SERUMINJECTABLE;INJECTION1,000uCi/MLNoNo
003JEANATOPEALBUMIN IODINATED I-125 SERUMINJECTABLE;INJECTION100uCi/10ML (10uCi/ML)NoNo

NDC Listings For This Application#

NDC listings for this application page 1 of 1 ยท 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50914-7732JeanatopeIodinated I-125 AlbuminIso-Tex Diagnostics, Inc.BLACurrent
50914-7732JeanatopeIodinated I-125 AlbuminIso-Tex Diagnostics, Inc.NDACurrent
50914-7732JeanatopeIodinated I-125 AlbuminIso-Tex Diagnostics, Inc.NDACurrent
50914-7733JeanatopeIodinated I-125 AlbuminIso-Tex Diagnostics, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74965SUPPL 2023-08-01
74745SUPPL 2023-07-13
66380APPL2020-03-23
721SUPPL2020-03-23