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FDA ANDA · ANDA206845
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
Sponsor: ACCORD HLTHCARE
APPLICATION
ANDA206845
TYPE
ANDA
ORIGINAL APPROVAL
2016-03-10
LATEST ACTION
2025-11-13
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEDiscontinued
ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML · INJECTABLE · INJECTION
Approval history
2025-11-13Labeling · Supplement 10 · standardAP
2023-05-24Labeling · Supplement 8 · standardAP
2021-10-01Labeling · Supplement 7 · standardAP
2021-10-01Labeling · Supplement 2 · standardAP
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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