FDA ANDA · ANDA077009

ONDANSETRON HYDROCHLORIDE

Sponsor: TARO

APPLICATION

ANDA077009

TYPE

ANDA

ORIGINAL APPROVAL

2007-11-30

LATEST ACTION

2018-04-23

ROUTE

ORAL

DOSAGE FORM

SOLUTION

MARKETING STATUS

Discontinued

Products

ONDANSETRON HYDROCHLORIDEDiscontinued

ONDANSETRON HYDROCHLORIDE EQ 4MG BASE/5ML · SOLUTION · ORAL

2018-04-23Labeling · Supplement 11 · standardAP

2017-03-30Labeling · Supplement 9 · standardAP

2014-12-20Labeling · Supplement 6 · standardAP

2014-12-20Labeling · Supplement 7 · standardAP

2012-04-27Labeling · Supplement 4AP

2011-04-29Labeling · Supplement 3AP

2007-11-30OriginalAP

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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