Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200435
Company: TEVA PHARMS

Products on ANDA 200435

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 5MG BASE;12.5MG;160MG	TABLET;ORAL	Discontinued	None	No	No
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 5MG BASE;25MG;160MG	TABLET;ORAL	Discontinued	None	No	No
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 10MG BASE;25MG;160MG	TABLET;ORAL	Discontinued	None	No	No
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 10MG BASE;25MG;320MG	TABLET;ORAL	Discontinued	None	No	No
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 10MG BASE;12.5MG;160MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 200435

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/25/2012	ORIG-1	Approval	Not Applicable		Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200435Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/11/2015	SUPPL-4	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
01/02/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
01/02/2015	SUPPL-1	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.