FDA Product

Volumex

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Volumex

FDA Product Code

50914-7720

Regulatory Information

NDC Product Code

50914-7720

Application Number

BLA017837

Marketing Category

C73585

Effective Date

November 21, 2022

Territorial Authority

USA

FDA Title

Volumex

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

5

Company Information

ManufacturerIso-Tex Diagnostics, Inc.

DUNS Number

181202995

Active Ingredients

HUMAN SERUM ALBUMIN I-131

Quantity: 0.025 mCi in 1 mL

Code: ACH35131L1

Class Code: ACTIB

BENZYL ALCOHOL

Code: LKG8494WBH

Class Code: IACT

ALBUMIN HUMAN

Code: ZIF514RVZR

Class Code: IACT

Active Moieties

HUMAN SERUM ALBUMIN I-131

Code: ACH35131L1

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