Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 200435
Company: TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 5MG;12.5MG;160MG TABLET;ORAL Discontinued None No No
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 5MG;25MG;160MG TABLET;ORAL Discontinued None No No
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10MG;25MG;160MG TABLET;ORAL Discontinued None No No
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10MG;25MG;320MG TABLET;ORAL Discontinued None No No
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10MG;12.5MG;160MG TABLET;ORAL Discontinued None No No
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-Patient Package Insert, Labeling-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.

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