FDA ANDA · ANDA206846
ONDANSETRON
Sponsor: ACCORD HLTHCARE
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APPLICATION
ANDA206846
TYPE
ANDA
ORIGINAL APPROVAL
2015-07-13
LATEST ACTION
2026-10-13
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
ONDANSETRON HYDROCHLORIDEPrescription
ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML · INJECTABLE · INJECTION
Approval history
2026-10-13Labeling · Supplement 12 · standardAP
2026-10-13Labeling · Supplement 10 · standardAP
2023-05-24Labeling · Supplement 8 · standardAP
2021-10-01Labeling · Supplement 7 · standardAP
2021-10-01Labeling · Supplement 2 · standardAP
2015-07-13UNKNOWN · Original · standardAP
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