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FDA ANDA · ANDA202253
ONDANSETRON
ondansetron hydrochloride
Sponsor: FRESENIUS KABI USA
APPLICATION
ANDA202253
TYPE
ANDA
ORIGINAL APPROVAL
2013-07-19
LATEST ACTION
2024-07-08
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
2024-07-08Labeling · Supplement 8 · standardAP
2024-07-08Manufacturing (CMC) · Supplement 12 · standardAP
2024-07-08Labeling · Supplement 13 · standardAP
2015-11-16Labeling · Supplement 5AP
2015-10-22Labeling · Supplement 4 · standardAP
2015-10-22Labeling · Supplement 7 · standardAP
2015-10-09Manufacturing (CMC) · Supplement 1 · unknownAP
2013-07-19OriginalAP
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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