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FDA ANDA · ANDA078776
ONDANSETRON
ondansetron hydrochloride
Sponsor: AUROBINDO PHARMA
APPLICATION
ANDA078776
TYPE
ANDA
ORIGINAL APPROVAL
2007-11-28
LATEST ACTION
2025-10-23
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
ONDANSETRON HYDROCHLORIDEPrescription
ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML · SOLUTION · ORAL
Approval history
2025-10-23Labeling · Supplement 19 · standardAP
2022-06-23Labeling · Supplement 15 · standardAP
2022-06-23Labeling · Supplement 14 · standardAP
2018-03-07Labeling · Supplement 10 · standardAP
2017-03-27Labeling · Supplement 9 · standardAP
2014-12-08Labeling · Supplement 7 · standardAP
2014-12-08Labeling · Supplement 5 · standardAP
2011-10-13Labeling · Supplement 2AP
2011-01-20Labeling · Supplement 1AP
2007-11-28OriginalAP
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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