Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091235
Company: TEVA PHARMS USA

Products on ANDA 091235

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091235

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/30/2015	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
10/27/2015	SUPPL-1	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.