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FDA BLA · BLA761149

ENSPRYNG

satralizumab

Sponsor: GENENTECH

APPLICATION
BLA761149
TYPE
BLA
ORIGINAL APPROVAL
2020-08-14
LATEST ACTION
2026-06-10
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ENSPRYNGPrescription
SATRALIZUMAB 120MG/ML · INJECTABLE · INJECTION

Approval history

2026-06-10Manufacturing (CMC) · Supplement 7AP
2022-09-14Labeling · Supplement 5 · standard — Label ↗AP
2021-05-03Labeling · Supplement 2 · standard — Letter ↗AP
2020-08-14Type 1 - New Molecular Entity · 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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