APPLICATION
ANDA206416
TYPE
ANDA
ORIGINAL APPROVAL
2018-09-19
LATEST ACTION
2025-05-23
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
PALONOSETRON HYDROCHLORIDEPrescription
PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) · INJECTABLE · INTRAVENOUS
Approval history
2025-05-23Labeling · Supplement 1 · standardAP
2018-09-19UNKNOWN · Original · 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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