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FDA BLA · BLA761219

ADALIMUMAB

adalimumab-aaty

Sponsor: CELLTRION

APPLICATION
BLA761219
TYPE
BLA
ORIGINAL APPROVAL
2023-05-23
LATEST ACTION
2025-10-16
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

YUFLYMAPrescription
ADALIMUMAB-AATY 40MG/0.4ML · INJECTABLE · INJECTION

Approval history

2025-10-16BIOSIMILAR · Supplement 18 — Letter ↗AP
2025-05-21Supplement · Supplement 9 — Letter ↗AP
2025-05-21Labeling · Supplement 16 · standard — Letter ↗AP
2025-04-07BIOSIMILAR · Supplement 17 · standard — Label ↗AP
2024-12-23Labeling · Supplement 13 · standard — Label ↗AP
2024-08-16Labeling · Supplement 11 · standard — Letter ↗AP
2023-12-22Labeling · Supplement 8 · standard — Letter ↗AP
2023-12-22Bioequivalence · Supplement 6 — Letter ↗AP
2023-12-22Labeling · Supplement 7 · standard — Letter ↗AP
2023-11-30Labeling · Supplement 2 · standard — Label ↗AP
2023-10-02Manufacturing (CMC) · Supplement 1 · standard — Label ↗AP
2023-09-21Labeling · Supplement 4 · standard — Letter ↗AP
2023-09-06Labeling · Supplement 3 · standard — Letter ↗AP
2023-05-23Type 2 - New Active Ingredient · Original · standard — Label ↗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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