Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091519
Company: WATSON LABS TEVA

Products on ANDA 091519

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	12.5MG;80MG	TABLET;ORAL	Discontinued	None	No	No
VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	12.5MG;160MG	TABLET;ORAL	Discontinued	None	No	No
VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	12.5MG;320MG	TABLET;ORAL	Discontinued	None	No	No
VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	25MG;160MG	TABLET;ORAL	Discontinued	None	No	No
VALSARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; VALSARTAN	25MG;320MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091519

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/21/2013	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
07/17/2023	SUPPL-5	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
07/17/2023	SUPPL-4	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.