FDA Product

Megatope

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

Basic Information

Product Name

Megatope

FDA Product Code

50914-7731

Regulatory Information

NDC Product Code

50914-7731

Application Number

BLA017837

Marketing Category

C73585

Effective Date

September 1, 2023

Territorial Authority

USA

FDA Title

MEGATOPE

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

4

Company Information

ManufacturerIso-Tex Diagnostics, Inc.

DUNS Number

181202995

Active Ingredients

HUMAN SERUM ALBUMIN I-131

Quantity: 1 mCi in 1 mL

Code: ACH35131L1

Class Code: ACTIB

ALBUMIN HUMAN

Code: ZIF514RVZR

Class Code: IACT

BENZYL ALCOHOL

Code: LKG8494WBH

Class Code: IACT

Active Moieties

HUMAN SERUM ALBUMIN I-131

Code: ACH35131L1

© Copyright 2025. All Rights Reserved by MedPath

Home Terms & Conditions Privacy Policy