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FDA BLA · BLA761071

ADALIMUMAB

adalimumab-adaz

Sponsor: SANDOZ INC

APPLICATION
BLA761071
TYPE
BLA
ORIGINAL APPROVAL
2018-10-30
LATEST ACTION
2025-10-16
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

HYRIMOZPrescription
ADALIMUMAB-ADAZ 40MG/0.8ML · INJECTABLE · INJECTION

Approval history

2025-10-16BIOSIMILAR · Supplement 31 — Letter ↗AP
2025-07-29Labeling · Supplement 24 · standard — Label ↗AP
2025-05-20Supplement · Supplement 22 — Letter ↗AP
2024-06-12Labeling · Supplement 21 · standard — Letter ↗AP
2024-04-05Bioequivalence · Supplement 19 · unknown — Letter ↗AP
2023-09-08Bioequivalence · Supplement 16 — Letter ↗AP
2023-04-14UNKNOWN · Supplement 15 · standard — Label ↗AP
2023-03-20Efficacy · Supplement 14 · standard — Letter ↗AP
2022-07-18Efficacy · Supplement 12 · standard — Letter ↗AP
2022-07-18Efficacy · Supplement 10 · standard — Letter ↗AP
2022-03-28Manufacturing (CMC) · Supplement 11 — Letter ↗AP
2021-02-24Labeling · Supplement 1 · standard — Letter ↗AP
2018-10-30Type 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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