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FDA BLA · BLA761118

ABRILADA

adalimumab-afzb

Sponsor: PFIZER INC

APPLICATION
BLA761118
TYPE
BLA
ORIGINAL APPROVAL
2019-11-15
LATEST ACTION
2025-12-17
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ABRILADAPrescription
ADALIMUMAB-AFZB 10MG/0.2ML · INJECTABLE · INJECTION
ABRILADAPrescription
ADALIMUMAB-AFZB 40MG/0.8ML · INJECTABLE · INJECTION
ABRILADAPrescription
ADALIMUMAB-AFZB 20MG/0.4ML · INJECTABLE · INJECTION

Approval history

2025-12-17Type 2 - New Active Ingredient · Supplement 20 · standard — Letter ↗AP
2024-04-30Labeling · Supplement 12 · standard — Label ↗AP
2023-10-04Efficacy · Supplement 7 · standard — Letter ↗AP
2023-08-16Bioequivalence · Supplement 11 — Letter ↗AP
2023-06-14Efficacy · Supplement 9 · standard — Letter ↗AP
2022-07-29Efficacy · Supplement 6 · standard — Letter ↗AP
2019-11-15Type 2 - New Active Ingredient · 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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