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FDA BLA · BLA761065

TROGARZO

ibalizumab

Sponsor: THERATECHNOLOGIES

APPLICATION
BLA761065
TYPE
BLA
ORIGINAL APPROVAL
2018-03-06
LATEST ACTION
2023-12-12
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

TROGARZOPrescription
IBALIZUMAB-UIYK 150MG/ML · INJECTABLE · INJECTION

Approval history

2023-12-12Labeling · Supplement 20 · standard — Letter ↗AP
2022-10-03Efficacy · Supplement 13 · standard — Label ↗AP
2021-04-22Labeling · Supplement 11 · standard — Letter ↗AP
2020-04-17Labeling · Supplement 8 · 901 required — Letter ↗AP
2018-05-30Labeling · Supplement 1 · standard — Letter ↗AP
2018-03-06Type 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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