FDA BLA · BLA103293

PROLEUKIN

aldesleukin

Sponsor: CHIRON

APPLICATION

BLA103293

TYPE

BLA

ORIGINAL APPROVAL

1992-05-05

LATEST ACTION

2023-09-29

ROUTE

INTRAVENOUS

DOSAGE FORM

VIAL

MARKETING STATUS

Prescription

Products

PROLEUKINPrescription

ALDESLEUKIN 22MIU/VIAL · VIAL

2023-09-29Labeling · Supplement 5154 · standard — Label ↗AP

2019-05-17Labeling · Supplement 5146 · standard — Letter ↗AP

2015-05-06Labeling · Supplement 5139 · standardAP

2012-07-30Labeling · Supplement 5130 · standard — Label ↗AP

2011-12-16Labeling · Supplement 5123 · standard — Letter ↗AP

2011-07-19Labeling · Supplement 5114 · standard — Letter ↗AP

2010-07-06Labeling · Supplement 5099 · standardAP

2010-03-17Labeling · Supplement 5088 · standardAP

2009-04-08Labeling · Supplement 5087 · standardAP

2000-06-27Labeling · Supplement 1029 · standardAP

1998-01-09Efficacy · Supplement 1019 · unknownAP

1998-01-09Efficacy · Supplement 1021 · priority — Review ↗AP

1992-05-05Type 1 - New Molecular Entity · Original · unknownAP

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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