← FDA DRUG APPROVALS

FDA NDA · NDA205718

AKYNZEO

netupitant and palonosetron

Sponsor: HELSINN HLTHCARE

APPLICATION
NDA205718
TYPE
NDA
ORIGINAL APPROVAL
2014-10-10
LATEST ACTION
2021-06-02
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

AKYNZEO · ReferencePrescription
NETUPITANT 300MG, PALONOSETRON HYDROCHLORIDE EQ 0.5MG BASE · CAPSULE · ORAL

Approval history

2021-06-02Labeling · Supplement 9 · standard — Label ↗AP
2016-12-28Labeling · Supplement 8 · standardAP
2016-04-12Manufacturing (CMC) · Supplement 6 · standardAP
2015-07-20Manufacturing (CMC) · Supplement 5 · standardAP
2015-05-13Labeling · Supplement 4 · standardAP
2015-04-29Labeling · Supplement 2 · standard — Label ↗AP
2015-04-27Labeling · Supplement 3 · standard — Label ↗AP
2015-02-16Manufacturing (CMC) · Supplement 1 · standardAP
2014-10-10Type 1 - New Molecular Entity and Type 4 - New Combination · 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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