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FDA ANDA · ANDA205648
PALONOSETRON
palonosetron hydrochloride
Sponsor: QILU PHARM HAINAN
APPLICATION
ANDA205648
TYPE
ANDA
ORIGINAL APPROVAL
2018-09-19
LATEST ACTION
2023-08-25
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription
Products
PALONOSETRON HYDROCHLORIDEDiscontinued
PALONOSETRON HYDROCHLORIDE EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) · INJECTABLE · INTRAVENOUS
PALONOSETRON HYDROCHLORIDEPrescription
PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) · INJECTABLE · INTRAVENOUS
Approval history
2023-08-25Labeling · Supplement 3 · standardAP
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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