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FDA NDA · NDA206910

JADENU

deferasirox

Sponsor: NOVARTIS PHARMS CORP

APPLICATION
NDA206910
TYPE
NDA
ORIGINAL APPROVAL
2015-03-30
LATEST ACTION
2022-02-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

JADENU · ReferencePrescription
DEFERASIROX 180MG · TABLET · ORAL
JADENU · ReferencePrescription
DEFERASIROX 360MG · TABLET · ORAL
JADENU · ReferencePrescription
DEFERASIROX 90MG · TABLET · ORAL

Approval history

2022-02-11Manufacturing (CMC) · Supplement 19 — Label ↗AP
2020-07-23Efficacy · Supplement 15 · standard — Letter ↗AP
2019-07-26Efficacy · Supplement 12 · standard — Letter ↗AP
2019-05-24Efficacy · Supplement 14 · priority — Label ↗AP
2018-12-12Efficacy · Supplement 9 · priority — Label ↗AP
2018-12-12Labeling · Supplement 11 · standard — Label ↗AP
2018-08-03Labeling · Supplement 10 · standard — Label ↗AP
2018-05-11Efficacy · Supplement 6 · standard — Label ↗AP
2018-02-16Labeling · Supplement 7 · standard — Label ↗AP
2018-01-26Labeling · Supplement 5 · standard — Label ↗AP
2016-08-12Labeling · Supplement 4 · standard — Label ↗AP
2015-11-06Manufacturing (CMC) · Supplement 2 · priorityAP
2015-10-22Labeling · Supplement 3 · standard — Label ↗AP
2015-10-22Labeling · Supplement 1 · standard — Label ↗AP
2015-03-30Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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