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FDA NDA · NDA202324

INLYTA

axitinib

Sponsor: PF PRISM CV

APPLICATION
NDA202324
TYPE
NDA
ORIGINAL APPROVAL
2012-01-27
LATEST ACTION
2024-07-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

INLYTA · ReferencePrescription
AXITINIB 1MG · TABLET · ORAL
INLYTA · ReferencePrescription
AXITINIB 5MG · TABLET · ORAL

Approval history

2024-07-16Labeling · Supplement 16 · standard — Letter ↗AP
2022-09-22Efficacy · Supplement 14 · standard — Label ↗AP
2020-06-04Efficacy · Supplement 11 · priority — Label ↗AP
2020-01-23Labeling · Supplement 10 · standard — Letter ↗AP
2018-08-10Labeling · Supplement 8 · standard — Label ↗AP
2016-06-16Manufacturing (CMC) · Supplement 5 · standardAP
2016-03-30Manufacturing (CMC) · Supplement 4 · standardAP
2014-12-29Labeling · Supplement 3 · standard — Label ↗AP
2014-08-01Labeling · Supplement 2 · standard — Label ↗AP
2013-09-16Labeling · Supplement 1 · standard — Letter ↗AP
2012-01-27Type 1 - New Molecular Entity · Original · standard — Review ↗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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