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FDA NDA · NDA207997

RYDAPT

Sponsor: NOVARTIS

APPLICATION
NDA207997
TYPE
NDA
ORIGINAL APPROVAL
2017-04-28
LATEST ACTION
2023-05-22
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

RYDAPT · ReferencePrescription
MIDOSTAURIN 25MG · CAPSULE · ORAL

Approval history

2023-05-22Labeling · Supplement 10 · standard — Label ↗AP
2021-11-15Labeling · Supplement 8 · standard — Label ↗AP
2021-04-20Labeling · Supplement 7 · standard — Letter ↗AP
2020-11-24Efficacy · Supplement 6 · priority — Label ↗AP
2020-03-04Labeling · Supplement 4 · standard — Letter ↗AP
2018-06-21Labeling · Supplement 2 · standard — Label ↗AP
2017-04-28Type 1 - New Molecular Entity · Original · priority — Label ↗AP
2017-04-28Efficacy · Original · priority — 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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