← FDA DRUG APPROVALS

FDA BLA · BLA761255

IDACIO

adalimumab-aacf

Sponsor: FRESENIUS KABI USA

APPLICATION
BLA761255
TYPE
BLA
ORIGINAL APPROVAL
2022-12-13
LATEST ACTION
2025-12-23
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

IDACIOPrescription
ADALIMUMAB-AACF 40MG/0.8ML · INJECTABLE · SUBCUTANEOUS

Approval history

2025-12-23BIOSIMILAR · Supplement 12 — Letter ↗AP
2024-12-18Labeling · Supplement 8 · standard — Label ↗AP
2024-06-04Labeling · Supplement 6 · standard — Letter ↗AP
2024-01-05Type 2 - New Active Ingredient · Original · standard — Letter ↗AP
2023-11-16Labeling · Supplement 4 · standard — Label ↗AP
2023-10-31BIOSIMILAR · Supplement 3 — Label ↗AP
2023-10-11BIOSIMILAR · Supplement 2 · standard — Label ↗AP
2022-12-13Type 2 - New Active Ingredient · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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