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FDA BLA · BLA103767

ONTAK

Sponsor: EISAI INC

APPLICATION
BLA103767
TYPE
BLA
ORIGINAL APPROVAL
1999-02-05
LATEST ACTION
2020-02-10
DOSAGE FORM
VIAL
MARKETING STATUS
Prescription

Products

ONTAKPrescription
DENILEUKIN DIFTITOX 150UG/ML · VIAL

Approval history

2020-02-10Labeling · Supplement 5144 · standard — Label ↗AP
2019-02-15Labeling · Supplement 5143 · standard — Label ↗AP
2011-08-30Supplement · Supplement 5119 — Label ↗AP
2010-03-05Labeling · Supplement 5118 · standardAP
2008-10-15Efficacy · Supplement 5094 · priority — Label ↗AP
1999-02-05Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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