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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077545
Company: HIKMA INTL PHARMS
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 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
09/06/2007 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
02/21/2018 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

02/21/2018 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

01/15/2015 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

02/27/2013 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

02/27/2013 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

02/27/2013 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

04/11/2008 SUPPL-2 Labeling

Label is not available on this site.

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