Drugs@FDA: FDA Approved Drug Products

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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 Prescription AB No No
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;10MG CAPSULE;ORAL Prescription AB No No
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;20MG CAPSULE;ORAL Prescription AB No No
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;20MG CAPSULE;ORAL Prescription AB No No
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE;ORAL Prescription AB No No
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE;ORAL Prescription AB 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
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-Container/Carton Labels, Labeling-Package Insert

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.

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE

CAPSULE;ORAL; EQ 2.5MG BASE;10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 2.5MG BASE;10MG CAPSULE;ORAL Prescription No AB 091431 APOTEX INC
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 2.5MG BASE;10MG CAPSULE;ORAL Prescription No AB 202239 AUROBINDO PHARMA LTD
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 2.5MG BASE;10MG CAPSULE;ORAL Prescription No AB 077183 DR REDDYS LABS INC
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 2.5MG BASE;10MG CAPSULE;ORAL Prescription No AB 078466 LUPIN PHARMS
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 2.5MG BASE;10MG CAPSULE;ORAL Prescription No AB 077375 MYLAN
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 2.5MG BASE;10MG CAPSULE;ORAL Prescription No AB 078381 PAR PHARM
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 2.5MG BASE;10MG CAPSULE;ORAL Prescription No AB 077179 TEVA PHARMS
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 2.5MG BASE;10MG CAPSULE;ORAL Prescription No AB 077890 WATSON LABS
LOTREL AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 2.5MG BASE;10MG CAPSULE;ORAL Prescription Yes AB 020364 NOVARTIS

CAPSULE;ORAL; EQ 5MG BASE;10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;10MG CAPSULE;ORAL Prescription No AB 091431 APOTEX INC
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;10MG CAPSULE;ORAL Prescription No AB 202239 AUROBINDO PHARMA LTD
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;10MG CAPSULE;ORAL Prescription No AB 077183 DR REDDYS LABS INC
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;10MG CAPSULE;ORAL Prescription No AB 078466 LUPIN PHARMS
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;10MG CAPSULE;ORAL Prescription No AB 077375 MYLAN
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;10MG CAPSULE;ORAL Prescription No AB 078381 PAR PHARM
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;10MG CAPSULE;ORAL Prescription No AB 077179 TEVA PHARMS
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;10MG CAPSULE;ORAL Prescription No AB 077890 WATSON LABS
LOTREL AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;10MG CAPSULE;ORAL Prescription Yes AB 020364 NOVARTIS

CAPSULE;ORAL; EQ 5MG BASE;20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;20MG CAPSULE;ORAL Prescription No AB 091431 APOTEX INC
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;20MG CAPSULE;ORAL Prescription No AB 202239 AUROBINDO PHARMA LTD
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;20MG CAPSULE;ORAL Prescription No AB 077183 DR REDDYS LABS INC
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;20MG CAPSULE;ORAL Prescription No AB 078466 LUPIN PHARMS
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;20MG CAPSULE;ORAL Prescription No AB 077375 MYLAN
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;20MG CAPSULE;ORAL Prescription No AB 078381 PAR PHARM
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;20MG CAPSULE;ORAL Prescription No AB 077179 TEVA PHARMS
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;20MG CAPSULE;ORAL Prescription No AB 077890 WATSON LABS
LOTREL AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;20MG CAPSULE;ORAL Prescription Yes AB 020364 NOVARTIS

CAPSULE;ORAL; EQ 10MG BASE;20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;20MG CAPSULE;ORAL Prescription No AB 091431 APOTEX INC
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;20MG CAPSULE;ORAL Prescription No AB 202239 AUROBINDO PHARMA LTD
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;20MG CAPSULE;ORAL Prescription No AB 077183 DR REDDYS LABS INC
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;20MG CAPSULE;ORAL Prescription No AB 078466 LUPIN PHARMS
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;20MG CAPSULE;ORAL Prescription No AB 077375 MYLAN
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;20MG CAPSULE;ORAL Prescription No AB 078381 PAR PHARM
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;20MG CAPSULE;ORAL Prescription No AB 077179 TEVA PHARMS
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;20MG CAPSULE;ORAL Prescription No AB 077890 WATSON LABS
LOTREL AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;20MG CAPSULE;ORAL Prescription Yes AB 020364 NOVARTIS

CAPSULE;ORAL; EQ 5MG BASE;40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE;ORAL Prescription No AB 091431 APOTEX INC
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE;ORAL Prescription No AB 202239 AUROBINDO PHARMA LTD
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE;ORAL Prescription No AB 090149 DR REDDYS LABS INC
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE;ORAL Prescription No AB 078466 LUPIN PHARMS
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE;ORAL Prescription No AB 079047 MYLAN
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE;ORAL Prescription No AB 078381 PAR PHARM
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE;ORAL Prescription No AB 077179 TEVA PHARMS
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE;ORAL Prescription No AB 090364 WATSON LABS INC
LOTREL AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE;ORAL Prescription Yes AB 020364 NOVARTIS

CAPSULE;ORAL; EQ 10MG BASE;40MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE;ORAL Prescription No AB 091431 APOTEX INC
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE;ORAL Prescription No AB 202239 AUROBINDO PHARMA LTD
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE;ORAL Prescription No AB 090149 DR REDDYS LABS INC
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE;ORAL Prescription No AB 078466 LUPIN PHARMS
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE;ORAL Prescription No AB 079047 MYLAN
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE;ORAL Prescription No AB 078381 PAR PHARM
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE;ORAL Prescription No AB 077179 TEVA PHARMS
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE;ORAL Prescription No AB 090364 WATSON LABS INC
LOTREL AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE;ORAL Prescription Yes AB 020364 NOVARTIS

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