FDA BLA · BLA017881

DRAXIMAGE MAA

kit for the preparation of technetium tc 99m albumin aggregated

Sponsor: DRAXIMAGE

APPLICATION

BLA017881

TYPE

BLA

ORIGINAL APPROVAL

1987-12-30

LATEST ACTION

2023-12-01

ROUTE

INTRAVENOUS, INJECTION

DOSAGE FORM

INJECTABLE

MARKETING STATUS

Prescription

Products

TECHNETIUM TC 99M ALBUMIN AGGREGATED KITPrescription

TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT N/A · INJECTABLE · INJECTION

2023-12-01Labeling · Supplement 30 · standard — Label ↗AP

2017-10-20Manufacturing (CMC) · Supplement 26 · standard — Label ↗AP

2016-06-09Manufacturing (CMC) · Supplement 25 · standard — Letter ↗AP

2016-03-01Manufacturing (CMC) · Supplement 24 · standardAP

2015-05-11Manufacturing (CMC) · Supplement 23 · standardAP

2013-03-04Manufacturing (CMC) · Supplement 22 · standardAP

2011-09-23Labeling · Supplement 16 · standard — Label ↗AP

2009-06-05Manufacturing (CMC) · Supplement 10 — Label ↗AP

2008-10-17Labeling · Supplement 9 · standard — Letter ↗AP

2002-07-23Manufacturing (CMC) · Supplement 4 · standard — Letter ↗AP

1999-04-02Labeling · Supplement 2 · standardAP

1999-04-02Labeling · Supplement 3 · standardAP

1989-07-17Labeling · Supplement 1AP

1987-12-30Type 5 - New Formulation or New Manufacturer · Original · standardAP

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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