Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 201505
Company: APOTEX INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;150MG TABLET;ORAL Discontinued None No No
IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;300MG TABLET;ORAL Discontinued None No No
IRBESARTAN HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 25MG;300MG TABLET; ORAL None (Tentative Approval) 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
10/15/2012 ORIG-2 Tentative Approval Not Applicable

Label is not available on this site.

10/15/2012 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/17/2015 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

02/17/2015 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

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