Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078211
Company: SUN PHARM INDS LTD

Products on ANDA 078211

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE	12.5MG;EQ 10MG BASE	TABLET;ORAL	Discontinued	None	No	No
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE	12.5MG;EQ 20MG BASE	TABLET;ORAL	Discontinued	None	No	No
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE	25MG;EQ 20MG BASE	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078211

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/04/2009	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
12/04/2015	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
12/04/2015	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
12/02/2014	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
12/02/2014	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
12/02/2014	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
12/02/2014	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
12/02/2014	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
12/02/2014	SUPPL-2	Labeling-Package Insert		Label is not available on this site.