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FDA BLA · BLA761299

ADALIMUMAB-RYVK

Sponsor: ALVOTECH USA INC

APPLICATION
BLA761299
TYPE
BLA
ORIGINAL APPROVAL
2024-02-23
LATEST ACTION
2025-11-06
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

SIMLANDIPrescription
ADALIMUMAB-RYVK 40MG/0.4ML · INJECTABLE · INJECTION

Approval history

2025-11-06Labeling · Supplement 24 · standard — Letter ↗AP
2025-10-16BIOSIMILAR · Supplement 25 — Letter ↗AP
2025-04-07Manufacturing (CMC) · Supplement 20 — Label ↗AP
2025-04-07Manufacturing (CMC) · Supplement 13 · standard — Label ↗AP
2025-02-14Manufacturing (CMC) · Supplement 16 — Label ↗AP
2024-08-26Labeling · Supplement 3 · standard — Letter ↗AP
2024-08-26Labeling · Supplement 6 · standard — Letter ↗AP
2024-06-26Manufacturing (CMC) · Supplement 7 — Letter ↗AP
2024-05-31Labeling · Supplement 1 · standard — Letter ↗AP
2024-02-23UNKNOWN · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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