← FDA DRUG APPROVALS

FDA NDA · NDA207968

JADENU

deferasirox

Sponsor: NOVARTIS

APPLICATION
NDA207968
TYPE
NDA
ORIGINAL APPROVAL
2017-05-18
LATEST ACTION
2020-07-23
ROUTE
ORAL
DOSAGE FORM
GRANULE
MARKETING STATUS
Prescription

Products

JADENU SPRINKLE · ReferencePrescription
DEFERASIROX 180MG · GRANULE · ORAL
JADENU SPRINKLE · ReferencePrescription
DEFERASIROX 360MG · GRANULE · ORAL
JADENU SPRINKLE · ReferencePrescription
DEFERASIROX 90MG · GRANULE · ORAL

Approval history

2020-07-23Efficacy · Supplement 9 · standard — Letter ↗AP
2019-07-25Efficacy · Supplement 7 · standard — Letter ↗AP
2019-05-24Efficacy · Supplement 8 · priority — Label ↗AP
2018-12-12Labeling · Supplement 6 · standard — Label ↗AP
2018-12-12Efficacy · Supplement 4 · priority — Label ↗AP
2018-08-03Labeling · Supplement 5 · standard — Label ↗AP
2018-05-11Efficacy · Supplement 1 · standard — Label ↗AP
2018-02-16Labeling · Supplement 2 · standard — Label ↗AP
2017-05-18Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma 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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