APPLICATION
ANDA077011
TYPE
ANDA
ORIGINAL APPROVAL
2006-12-26
LATEST ACTION
2013-04-03
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEPrescription
ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML · INJECTABLE · INJECTION
Approval history
2013-04-03Labeling · Supplement 8 · standardAP
2013-04-03Labeling · Supplement 6 · standardAP
2010-11-30Labeling · Supplement 1AP
2010-11-30Labeling · Supplement 2AP
2006-12-26OriginalAP
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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