Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077732
Company: HIKMA

Products on ANDA 077732

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM	12.5MG;100MG	TABLET;ORAL	Discontinued	None	No	No
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM	12.5MG;50MG	TABLET;ORAL	Discontinued	None	No	No
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM	25MG;100MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077732

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/06/2010	ORIG-2	Approval				Label is not available on this site.
04/06/2010	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/077732s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/18/2023	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
07/13/2022	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
01/28/2020	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
01/28/2020	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
02/21/2017	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
06/13/2015	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
06/13/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
01/28/2013	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
09/30/2011	SUPPL-1	Labeling-Package Insert		Label is not available on this site.