Jeanatope
Jeanatope
Approved
Approval ID
7b6f6a5e-f456-4db9-a3da-44d870ee6547
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 30, 2020
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 Code50914-7732
Application NumberBLA017836
Product Classification
M
Marketing Category
C73585
G
Generic Name
Iodinated I-125 Albumin
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJune 30, 2020
FDA Product Classification
INGREDIENTS (3)
HUMAN SERUM ALBUMIN I-125Active
Quantity: 0.01 mCi in 1 mL
Code: 68WQQ3N9TI
Classification: ACTIB
ALBUMIN HUMANInactive
Code: ZIF514RVZR
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT