APPLICATION
ANDA202600
TYPE
ANDA
ORIGINAL APPROVAL
2012-12-21
LATEST ACTION
2023-09-26
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEDiscontinued
ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML · INJECTABLE · INJECTION
Approval history
2023-09-26Manufacturing (CMC) · Supplement 13 · standardAP
2022-03-01Labeling · Supplement 11 · standardAP
2021-08-19Labeling · Supplement 7 · standardAP
2021-08-19Labeling · Supplement 10 · standardAP
2015-01-09Labeling · Supplement 6 · standardAP
2015-01-09Labeling · Supplement 4 · standardAP
2012-12-21UNKNOWN · OriginalAP
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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