Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077343
Company: APOTEX INC
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
12/31/2014 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

12/31/2014 SUPPL-7 Labeling-Container/Carton Labels

Label is not available on this site.

12/31/2014 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

06/19/2007 SUPPL-2 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

06/14/2007 SUPPL-1 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

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