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FDA ANDA · ANDA077303

ONDANSETRON

Sponsor: CHARTWELL MOLECULES

APPLICATION
ANDA077303
TYPE
ANDA
ORIGINAL APPROVAL
2007-06-25
LATEST ACTION
2018-02-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, None (Tentative Approval)

Products

ONDANSETRON HYDROCHLORIDEPrescription
ONDANSETRON HYDROCHLORIDE EQ 24MG BASE · TABLET · ORAL
ONDANSETRON HYDROCHLORIDEPrescription
ONDANSETRON HYDROCHLORIDE EQ 8MG BASE · TABLET · ORAL
ONDANSETRON HYDROCHLORIDENone (Tentative Approval)
ONDANSETRON HYDROCHLORIDE 16MG · TABLET · ORAL
ONDANSETRON HYDROCHLORIDEPrescription
ONDANSETRON HYDROCHLORIDE EQ 4MG BASE · TABLET · ORAL

Approval history

2018-02-26Labeling · Supplement 2 · standardAP
2015-10-23Labeling · Supplement 1 · standardAP
2007-06-25OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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