← FDA DRUG APPROVALS

FDA BLA · BLA761154

HULIO

adalimumab-fkjp

Sponsor: MYLAN PHARMS INC

APPLICATION
BLA761154
TYPE
BLA
ORIGINAL APPROVAL
2020-07-06
LATEST ACTION
2025-02-05
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

HULIOPrescription
ADALIMUMAB-FKJP 20MG · INJECTABLE · INJECTION

Approval history

2025-02-05BIOSIMILAR · Supplement 9 · standard — Label ↗AP
2023-12-15Labeling · Supplement 8 · standard — Letter ↗AP
2023-08-25Bioequivalence · Supplement 5 — Letter ↗AP
2023-03-03UNKNOWN · Supplement 3 · standard — Label ↗AP
2022-07-14Efficacy · Supplement 2 · standard — Letter ↗AP
2020-07-06UNKNOWN · 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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