Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201505
Company: APOTEX INC

Products on ANDA 201505

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201505

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.