APPLICATION
ANDA077557
TYPE
ANDA
ORIGINAL APPROVAL
2007-08-02
LATEST ACTION
2022-11-09
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Prescription
Products
ONDANSETRONPrescription
ONDANSETRON 4MG · TABLET, ORALLY DISINTEGRATING · ORAL
ONDANSETRONPrescription
ONDANSETRON 8MG · TABLET, ORALLY DISINTEGRATING · ORAL
Approval history
2022-11-09Labeling · Supplement 23 · standardAP
2022-11-09Labeling · Supplement 26 · standardAP
2018-03-14Labeling · Supplement 15 · standardAP
2017-03-24Labeling · Supplement 13 · standardAP
2017-03-24Labeling · Supplement 14 · standardAP
2016-02-28Labeling · Supplement 10 · standardAP
2013-10-07Labeling · Supplement 7 · standardAP
2013-04-26Labeling · Supplement 6 · standardAP
2008-06-18Labeling · Supplement 2AP
2007-08-02OriginalAP
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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