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FDA BLA · BLA761058

ADALIMUMAB-ADBM

Sponsor: BOEHRINGER INGELHEIM

APPLICATION
BLA761058
TYPE
BLA
ORIGINAL APPROVAL
2017-08-25
LATEST ACTION
2025-10-16
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

CYLTEZOPrescription
ADALIMUMAB-ADBM 40MG/0.8ML · INJECTABLE · INJECTION

Approval history

2025-10-16Bioequivalence · Supplement 35 — Letter ↗AP
2025-05-20Efficacy · Supplement 31 · standard — Letter ↗AP
2024-04-30Efficacy · Supplement 26 · standard — Label ↗AP
2023-07-19Labeling · Supplement 25 · standard — Letter ↗AP
2023-06-30Efficacy · Supplement 18 · standard — Label ↗AP
2023-05-18Efficacy · Supplement 16 · standard — Letter ↗AP
2023-03-22Efficacy · Supplement 13 · standard — Letter ↗AP
2022-10-03Labeling · Supplement 14 · standard — Letter ↗AP
2022-03-18Labeling · Supplement 11 · standard — Letter ↗AP
2021-10-15Efficacy · Supplement 8 · standard — Label ↗AP
2019-09-13Labeling · Supplement 3 · standard — Label ↗AP
2017-08-25Type 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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