← FDA DRUG APPROVALS

FDA BLA · BLA761116

ELZONRIS

tagraxofusp

Sponsor: STEMLINE THERAPEUTICS INC

APPLICATION
BLA761116
TYPE
BLA
ORIGINAL APPROVAL
2018-12-21
LATEST ACTION
2023-07-26
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

ELZONRISPrescription
TAGRAXOFUSP-ERZS 1000MCG · SOLUTION · INJECTION

Approval history

2023-07-26Labeling · Supplement 9 · standard — Letter ↗AP
2022-11-03Labeling · Supplement 7 · standard — Letter ↗AP
2022-10-27Efficacy · Supplement 5 · standard — Letter ↗AP
2018-12-21Type 1 - New Molecular Entity · Original · priority — 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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