Megatope

BLA 17837, held by Iso Tex. Albumin Iodinated I-131 Serum.

As of Nov 13, 2026, BLA 17837 (Megatope), held by Iso Tex, was first approved by FDA on Feb 23, 1976, with 13 approved supplements and 0 published complete response letters.

First approved: Feb 23, 1976
Review: Standard
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE MEGATOPE is indicated in adults for use in determinations of total blood and plasma volumes.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Feb 23, 1976	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

5 strengths and forms

Product	Active ingredient	Marketing
Megatope0.5mCi/VIAL · injectable;injection	Albumin Iodinated I-131 Serum	Rx
Megatope1mCi/VIAL · injectable;injection	Albumin Iodinated I-131 Serum	Rx
Megatope2mCi/VIAL · injectable;injection	Albumin Iodinated I-131 Serum	Discontinued
Megatope5uCi/AMP · injectable;injection	Albumin Iodinated I-131 Serum	Discontinued
Megatope20uCi/AMP · injectable;injection	Albumin Iodinated I-131 Serum	Discontinued

All 14 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Aug 25, 2023	Supplement 17Labeling · Standard review	Approved	Label Letter
May 21, 1996	Supplement 15Manufacturing · Standard review	Approved	None posted
Sep 30, 1985	Supplement 13Manufacturing · Standard review	Approved	None posted
Jan 22, 1985	Supplement 12Labeling	Approved	None posted
Oct 25, 1983	Supplement 10Labeling	Approved	None posted
Oct 4, 1983	Supplement 11Manufacturing · Standard review	Approved	None posted
Aug 17, 1981	Supplement 9Manufacturing · Standard review	Approved	None posted
Nov 16, 1978	Supplement 6Labeling	Approved	None posted
Oct 14, 1977	Supplement 5Labeling	Approved	None posted
Oct 14, 1977	Supplement 4Manufacturing · Standard review	Approved	None posted
Oct 14, 1977	Supplement 3Labeling	Approved	None posted
Oct 14, 1977	Supplement 2Labeling	Approved	None posted
Oct 14, 1977	Supplement 1Labeling	Approved	None posted
Feb 23, 1976	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: BLA 17837
Drugs@FDA: Overview at FDA
Company: Iso-Tex Diagnostics

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters