FDA ANDA · ANDA091342

ONDANSETRON HYDROCHLORIDE

Sponsor: CHARTWELL MOLECULAR

APPLICATION

ANDA091342

TYPE

ANDA

ORIGINAL APPROVAL

2011-01-27

LATEST ACTION

2022-06-23

ROUTE

ORAL

DOSAGE FORM

SOLUTION

MARKETING STATUS

Prescription

Products

ONDANSETRON HYDROCHLORIDEPrescription

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

2022-06-23Labeling · Supplement 8 · standardAP

2018-03-14Labeling · Supplement 6 · standardAP

2018-03-14Labeling · Supplement 5 · standardAP

2016-03-03Manufacturing (CMC) · Supplement 4 · unknownAP

2015-01-14Labeling · Supplement 3 · standardAP

2011-10-13Labeling · Supplement 1AP

2011-01-27OriginalAP

2011-01-27Supplement 27AP

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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