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FDA BLA · BLA761074

OGIVRI

trastuzumab-dkst

Sponsor: MYLAN GMBH

APPLICATION
BLA761074
TYPE
BLA
ORIGINAL APPROVAL
2017-12-01
LATEST ACTION
2024-11-13
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

OGIVRIPrescription
TRASTUZUMAB-DKST 420MG/VIAL · INJECTABLE · INJECTION

Approval history

2024-11-13BIOSIMILAR · Supplement 30 · standard — Label ↗AP
2023-10-02Labeling · Supplement 27 · standard — Letter ↗AP
2019-06-28Labeling · Supplement 5 · standard — Letter ↗AP
2019-04-17Manufacturing (CMC) · Supplement 4 · standard — Label ↗AP
2017-12-01UNKNOWN · 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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