Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 076674
Company: COREPHARMA

Products on ANDA 076674

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076674

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/05/2004	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
08/20/2020	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
07/16/2020	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
11/18/2015	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
11/18/2015	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
11/18/2015	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
02/26/2014	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
02/26/2014	SUPPL-12	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
02/19/2010	SUPPL-11	Labeling		Label is not available on this site.
06/08/2006	SUPPL-5	Labeling		Label is not available on this site.
01/31/2006	SUPPL-2	Labeling		Label is not available on this site.