Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201087
Company: PAR PHARM
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;12.5MG;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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/01/2015 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/05/2021 SUPPL-7 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

04/05/2021 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

04/05/2021 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

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