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Macrotec

kit for the preparation of technetium Tc-99m albumin aggregated

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Macrotec

Proper name

kit for the preparation of technetium Tc-99m albumin aggregated

Licence type

351(a)

BLA number

017833

Applicant

Bracco Diagnostics Inc.

Center

CDER

Presentations

First licensure

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Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
1.5MG/10MG/0.07MG/0.19MG/1.8MG	For Injectable Suspension	Intravenous	Vial	Disc	February 23, 1976

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