← FDA DRUG APPROVALS

FDA NDA · NDA210493

AKYNZEO

fosnetupitant and palonosetron

Sponsor: HELSINN HLTHCARE

APPLICATION
NDA210493
TYPE
NDA
ORIGINAL APPROVAL
2018-04-19
LATEST ACTION
2023-02-15
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION, POWDER
MARKETING STATUS
Prescription, Discontinued

Products

AKYNZEO · ReferencePrescription
FOSNETUPITANT CHLORIDE HYDROCHLORIDE EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML), PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML) · SOLUTION · INTRAVENOUS
AKYNZEO · ReferenceDiscontinued
FOSNETUPITANT CHLORIDE HYDROCHLORIDE EQ 235MG BASE/VIAL, PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/VIAL · POWDER · INTRAVENOUS

Approval history

2023-02-15Labeling · Supplement 5 · standard — Letter ↗AP
2021-06-02Labeling · Supplement 4 · standard — Label ↗AP
2020-10-27Manufacturing (CMC) · Supplement 3 — Label ↗AP
2020-05-27Manufacturing (CMC) · Supplement 2 — Letter ↗AP
2020-02-24Manufacturing (CMC) · Supplement 1AP
2018-04-19Type 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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