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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077179
Company: TEVA PHARMS

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
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE;ORAL Discontinued None No No
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG 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
05/18/2007 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077179s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/18/2019 SUPPL-26 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.
01/04/2016 SUPPL-24 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.
01/04/2016 SUPPL-23 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.
01/04/2016 SUPPL-22 Labeling-Package Insert

Label is not available on this site.
10/26/2014 SUPPL-20 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.
02/23/2012 SUPPL-19 Labeling-Package Insert

Label is not available on this site.
12/31/2011 SUPPL-17 Labeling-Package Insert

Label is not available on this site.
08/31/2011 SUPPL-16 Labeling-Package Insert

Label is not available on this site.
05/23/2012 SUPPL-14 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.
04/22/2011 SUPPL-11 Labeling-Package Insert

Label is not available on this site.
01/24/2010 SUPPL-9 Labeling-Package Insert

Label is not available on this site.
01/13/2011 SUPPL-8 Labeling

Label is not available on this site.
07/05/2011 SUPPL-6 Labeling

Label is not available on this site.
07/05/2011 SUPPL-5

Label is not available on this site.
07/16/2007 SUPPL-1 Labeling

Label is not available on this site.
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