Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076240
Company: APOTEX INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE EQ 5MG BASE TABLET;ORAL Discontinued None No No
QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Discontinued None No No
QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Discontinued None No No
QUINAPRIL HYDROCHLORIDE QUINAPRIL HYDROCHLORIDE EQ 40MG 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
01/26/2006 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
06/08/2018 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

06/08/2018 SUPPL-13 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

02/08/2016 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

09/25/2014 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

09/25/2014 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

09/25/2014 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

08/31/2010 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

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