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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076930
Company: RISING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 4MG BASE TABLET;ORAL Discontinued None No No
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 8MG BASE TABLET;ORAL Discontinued None No No
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 16MG TABLET; ORAL None (Tentative Approval) None No No
ONDANSETRON HYDROCHLORIDE ONDANSETRON HYDROCHLORIDE EQ 24MG BASE TABLET;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/25/2007 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/07/2018 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

03/07/2018 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

03/18/2015 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

09/19/2013 SUPPL-6 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

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