← FDA DRUG APPROVALS

FDA BLA · BLA761073

KANJINTI

trastuzumab-anns

Sponsor: AMGEN INC

APPLICATION
BLA761073
TYPE
BLA
ORIGINAL APPROVAL
2019-06-13
LATEST ACTION
2024-12-19
ROUTE
INTRAVENOUS, SINGLE-DOSE, MULTIDOSE
DOSAGE FORM
VIAL
MARKETING STATUS
Prescription

Products

KANJINTIPrescription
TRASTUZUMAB-ANNS 150MG · VIAL · SINGLE-DOSE
KANJINTIPrescription
TRASTUZUMAB-ANNS 420MG · VIAL · MULTIDOSE

Approval history

2024-12-19BIOSIMILAR · Supplement 10 · unknown — Letter ↗AP
2019-10-25Supplement · Supplement 1 — Letter ↗AP
2019-06-13UNKNOWN · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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