Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 205357
Company: HUAREN PHARMACEUTICAL CO LTD

Products on ANDA 205357

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VALSARTAN	VALSARTAN	40MG	TABLET;ORAL	None (Tentative Approval)	None	No	No
VALSARTAN	VALSARTAN	80MG	TABLET;ORAL	None (Tentative Approval)	None	No	No
VALSARTAN	VALSARTAN	160MG	TABLET;ORAL	None (Tentative Approval)	None	No	No
VALSARTAN	VALSARTAN	320MG	TABLET;ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205357

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/01/2016	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.