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FDA BLA · BLA125418

ZALTRAP

ziv-aflibercept

Sponsor: SANOFI AVENTIS US

APPLICATION
BLA125418
TYPE
BLA
ORIGINAL APPROVAL
2012-08-03
LATEST ACTION
2023-12-13
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ZALTRAPPrescription
ZIV-AFLIBERCEPT 4MG · INJECTABLE · INJECTION

Approval history

2023-12-13Labeling · Supplement 54 · standard — Letter ↗AP
2020-06-05Labeling · Supplement 47 · standard — Label ↗AP
2020-03-11Labeling · Supplement 46 · standard — Letter ↗AP
2019-11-25Labeling · Supplement 45 · standard — Letter ↗AP
2016-06-24Labeling · Supplement 39 · standard — Label ↗AP
2016-03-09Labeling · Supplement 37 · standard — Label ↗AP
2015-09-17Efficacy · Supplement 33 · standard — Letter ↗AP
2013-10-25Labeling · Supplement 20 · standard — Label ↗AP
2012-08-03Type 1 - New Molecular Entity · Original · priority — Summary Review ↗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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