Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 076958
Company: TEVA

Products on ANDA 076958

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	25MG	TABLET;ORAL	Discontinued	None	No	No
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	50MG	TABLET;ORAL	Discontinued	None	No	No
LOSARTAN POTASSIUM	LOSARTAN POTASSIUM	100MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076958

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/06/2010	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/076958s001ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/30/2022	SUPPL-17	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
06/09/2016	SUPPL-14	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
10/22/2015	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
09/21/2014	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
09/21/2014	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
12/19/2012	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
12/19/2012	SUPPL-7	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
01/31/2011	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
01/31/2011	SUPPL-4	Labeling-Package Insert		Label is not available on this site.