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FDA BLA · BLA761042

ERELZI

Sponsor: SANDOZ

APPLICATION
BLA761042
TYPE
BLA
ORIGINAL APPROVAL
2016-08-30
LATEST ACTION
2022-11-10
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ERELZIPrescription
ETANERCEPT-SZZS 50MG/ML · INJECTABLE · INJECTION
ERELZIPrescription
ETANERCEPT-SZZS 25MG/0.5ML · INJECTABLE · INJECTION

Approval history

2022-11-10Efficacy · Supplement 18 · standard — Label ↗AP
2020-06-11Efficacy · Supplement 12 · unknown — Letter ↗AP
2019-10-18Efficacy · Supplement 10 · standard — Label ↗AP
2018-01-26Labeling · Supplement 1 · standard — Label ↗AP
2016-08-30UNKNOWN · Original · standard — Letter ↗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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