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FDA ANDA · ANDA203761

ONDANSETRON HYDROCHLORIDE

Sponsor: IPCA LABS LTD

APPLICATION
ANDA203761
TYPE
ANDA
ORIGINAL APPROVAL
2014-01-23
LATEST ACTION
2018-03-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ONDANSETRON HYDROCHLORIDEPrescription
ONDANSETRON HYDROCHLORIDE EQ 4MG BASE · TABLET · ORAL
ONDANSETRON HYDROCHLORIDEPrescription
ONDANSETRON HYDROCHLORIDE EQ 8MG BASE · TABLET · ORAL

Approval history

2018-03-07Labeling · Supplement 3 · standardAP
2018-03-07Labeling · Supplement 2 · standardAP
2015-04-02Labeling · Supplement 1 · standardAP
2014-01-23UNKNOWN · OriginalAP
VIEW ON DRUGS@FDA ↗

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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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