Jeanatope
JEANATOPE
Approved
Approval ID
60ec73ad-8128-478c-943f-70d22e1467e2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 8, 2023
Manufacturers
FDA
Iso-Tex Diagnostics, Inc.
DUNS: 181202995
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Iodinated I-125 Albumin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50914-7733
Application NumberBLA017836
Product Classification
M
Marketing Category
C73585
G
Generic Name
Iodinated I-125 Albumin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 14, 2022
FDA Product Classification
INGREDIENTS (3)
HUMAN SERUM ALBUMIN I-125Active
Quantity: 1000 uCi in 1 mL
Code: 68WQQ3N9TI
Classification: ACTIB
ALBUMIN HUMANInactive
Code: ZIF514RVZR
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT