← FDA DRUG APPROVALS

FDA NDA · NDA205266

ODOMZO

sonidegib

Sponsor: SUN PHARM

APPLICATION
NDA205266
TYPE
NDA
ORIGINAL APPROVAL
2015-07-24
LATEST ACTION
2023-08-22
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

ODOMZO · ReferencePrescription
SONIDEGIB PHOSPHATE EQ 200MG BASE · CAPSULE · ORAL

Approval history

2023-08-22Labeling · Supplement 9 · standard — Letter ↗AP
2019-05-13Labeling · Supplement 6 · standard — Label ↗AP
2017-09-18Efficacy · Supplement 4 · standard — Label ↗AP
2016-05-12Labeling · Supplement 2 · standard — Letter ↗AP
2016-02-17Labeling · Supplement 3 · standard — Label ↗AP
2015-07-24Type 1 - New Molecular Entity · Original · standard — Label ↗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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