Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076240
Company: APOTEX INC

Products on ANDA 076240

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076240

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.