Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077375
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 2.5MG BASE;10MG CAPSULE;ORAL Discontinued None No No
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;10MG CAPSULE;ORAL Discontinued None No No
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;20MG CAPSULE;ORAL Discontinued None No No
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;20MG CAPSULE;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
05/21/2010 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
01/04/2016 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

01/04/2016 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

01/04/2016 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

11/04/2014 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

12/31/2011 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

10/21/2011 SUPPL-2 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

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