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Chromalbin

albumin chromated CR-51 serum

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Chromalbin

Proper name

albumin chromated CR-51 serum

Licence type

351(a)

BLA number

017835

Applicant

Iso-Tex Diagnostics, Inc.

Center

CDER

Presentations

3

First licensure

—

Presentations

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
100uCi	Injection	Intravenous	Single-Dose Vial	Disc	February 23, 1976
250uCi	Injection	Intravenous	Single-Dose Vial	Disc	February 23, 1976
500uCi	Injection	Intravenous	Single-Dose Vial	Disc	February 23, 1976

Sources for this page

Purple Book	FDA	Licence type, presentations, reference product, exclusivity