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FDA BLA · BLA103795

ENBREL

etanercept

Sponsor: IMMUNEX

APPLICATION
BLA103795
TYPE
BLA
ORIGINAL APPROVAL
1998-11-02
LATEST ACTION
2026-01-30
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SYRINGE, VIAL
MARKETING STATUS
Prescription

Products

ENBRELPrescription
ETANERCEPT 50MG/ML · SYRINGE
ENBRELPrescription
ETANERCEPT 25MG/VIAL · VIAL · SUBCUTANEOUS

Approval history

2026-01-30Labeling · Supplement 5605 · standard — Letter ↗AP
2025-12-10Labeling · Supplement 5604 · standard — Letter ↗AP
2025-06-18Labeling · Supplement 5603 · standard — Label ↗AP
2024-09-12Labeling · Supplement 5600 · standard — Label ↗AP
2024-07-22Labeling · Supplement 5598 · standard — Letter ↗AP
2024-07-22Labeling · Supplement 5599 · standard — Letter ↗AP
2024-07-22Labeling · Supplement 5597 · standard — Letter ↗AP
2023-10-18Efficacy · Supplement 5595 · standard — Letter ↗AP
2023-06-09Labeling · Supplement 5594 · standard — Letter ↗AP
2022-08-16Labeling · Supplement 5591 · standard — Letter ↗AP
2022-06-17Labeling · Supplement 5590 · standard — Letter ↗AP
2021-02-26Labeling · Supplement 5582 · standard — Label ↗AP
2020-03-05Labeling · Supplement 5574 · standard — Label ↗AP
2020-03-05Manufacturing (CMC) · Supplement 5577 · unknown — Letter ↗AP
2019-02-14Labeling · Supplement 5571 · standard — Letter ↗AP
2018-10-03Labeling · Supplement 5569 · standard — Label ↗AP
2018-05-25UNKNOWN · Supplement 5563 · standard — Letter ↗AP
2018-05-25Labeling · Supplement 5564 · standard — Letter ↗AP
2018-05-11Labeling · Supplement 5565 · standard — Letter ↗AP
2017-11-22Efficacy · Supplement 5559 · standard — Letter ↗AP
2017-10-06Manufacturing (CMC) · Supplement 5561 · standard — Label ↗AP
2017-09-14Efficacy · Supplement 5556 · standard — Label ↗AP
2017-07-11Labeling · Supplement 5551 · standard — Label ↗AP
2016-11-04Efficacy · Supplement 5552 · standard — Letter ↗AP
2015-03-25Labeling · Supplement 5548 · standard — Label ↗AP
2015-03-20Supplement · Supplement 5532 — Label ↗AP
2013-11-15Labeling · Supplement 5531 · standard — Letter ↗AP
2012-12-10Labeling · Supplement 5507 · standard — Label ↗AP
2012-12-04Labeling · Supplement 5503 · standard — Label ↗AP
2011-12-22Labeling · Supplement 5484 · standardAP
2011-11-29Labeling · Supplement 5462 · standardAP
2011-09-07Labeling · Supplement 5475 · standard — Letter ↗AP
2011-08-10Labeling · Supplement 5474 · standardAP
2011-01-25Labeling · Supplement 5431 · standard — Letter ↗AP
2010-11-18Labeling · Supplement 5415 · standard — Label ↗AP
2010-10-13Labeling · Supplement 5445 · standard — Letter ↗AP
2010-09-29Labeling · Supplement 5443 · standard — Letter ↗AP
2010-07-29Labeling · Supplement 5437 · standard — Letter ↗AP
2010-07-20Labeling · Supplement 5391 · standard — Letter ↗AP
2010-06-03Labeling · Supplement 5397 · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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