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FDA ANDA · ANDA076972
ONDANSETRON
ondansetron hydrochloride
Sponsor: FRESENIUS KABI USA
APPLICATION
ANDA076972
TYPE
ANDA
ORIGINAL APPROVAL
2006-12-26
LATEST ACTION
2026-07-29
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEPrescription
ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML · INJECTABLE · INJECTION
Approval history
2026-07-29Labeling · Supplement 19 · standardAP
2022-06-10Labeling · Supplement 17 · standardAP
2022-06-10Labeling · Supplement 9 · standardAP
2022-06-10Labeling · Supplement 18 · standardAP
2022-06-10Labeling · Supplement 10 · standardAP
2014-12-08Labeling · Supplement 6 · standardAP
2014-12-08Labeling · Supplement 7 · standardAP
2014-12-08Labeling · Supplement 5 · standardAP
2011-02-25Labeling · Supplement 4AP
2006-12-26OriginalAP
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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