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FDA NDA · NDA214487

TAVNEOS

avacopan

Sponsor: CHEMOCENTRYX

APPLICATION
NDA214487
TYPE
NDA
ORIGINAL APPROVAL
2021-10-07
LATEST ACTION
2024-06-03
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

TAVNEOS · ReferencePrescription
AVACOPAN 10MG · CAPSULE · ORAL

Approval history

2024-06-03Labeling · Supplement 4 · standard — Letter ↗AP
2022-07-06Labeling · Supplement 1 · standard — Label ↗AP
2021-10-07Type 1 - New Molecular Entity · Original · standard — Letter ↗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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