Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076780
Company: HIKMA FARMACEUTICA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE ONDANSETRON HYDROCHLORIDE EQ 2MG BASE/ML INJECTABLE;INJECTION 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
12/26/2006 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
12/20/2014 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

12/20/2014 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

09/19/2013 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

04/30/2012 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

01/31/2011 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

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