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FDA ANDA · ANDA077173
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
Sponsor: SUN PHARM INDS LTD
APPLICATION
ANDA077173
TYPE
ANDA
ORIGINAL APPROVAL
2006-12-26
LATEST ACTION
2015-07-02
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEDiscontinued
ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML · INJECTABLE · INJECTION
Approval history
2015-07-02Labeling · Supplement 5 · standardAP
2015-07-02Labeling · Supplement 3 · standardAP
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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