Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020364
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOTREL AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 2.5MG BASE;10MG CAPSULE;ORAL Prescription AB Yes No
LOTREL AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;10MG CAPSULE;ORAL Prescription AB Yes No
LOTREL AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;20MG CAPSULE;ORAL Prescription AB Yes No
LOTREL AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;20MG CAPSULE;ORAL Prescription AB Yes No
LOTREL AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 10MG BASE;40MG CAPSULE;ORAL Prescription AB Yes Yes
LOTREL AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE EQ 5MG BASE;40MG CAPSULE;ORAL Prescription AB Yes 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
03/03/1995 ORIG-1 Approval Type 4 - New Combination STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/21/2017 SUPPL-65 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020364s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020364Orig1s065ltr.pdf
01/27/2017 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

02/08/2016 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

05/18/2015 SUPPL-61 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020364s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020364Orig1s061ltr.pdf
04/22/2015 SUPPL-60 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020364s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020364Orig1s060ltr.pdf
06/16/2015 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

12/31/2014 SUPPL-58 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020364s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020364Orig1s058ltr.pdf
10/05/2012 SUPPL-57 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020364s056s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020364Orig1s056,s057ltr.pdf
10/05/2012 SUPPL-56 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020364s056s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020364Orig1s056,s057ltr.pdf
01/19/2012 SUPPL-55 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020364s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020364s055ltr.pdf
10/28/2011 SUPPL-54 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020364s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020364s054ltr.pdf
06/20/2011 SUPPL-52 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020364s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020364s052ltr.pdf
01/04/2011 SUPPL-50 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020364s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020364s050ltr.pdf
12/22/2009 SUPPL-48 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020364s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020364s048ltr.pdf
03/29/2010 SUPPL-47 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020364s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020364s047ltr.pdf
10/28/2009 SUPPL-46 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020364s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020364s046ltr.pdf
08/31/2007 SUPPL-39 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020364s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020364s039ltr.pdf
02/23/2007 SUPPL-36 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020364s036ltr.pdf
08/11/2004 SUPPL-28 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20364s028ltr.pdf
07/02/2004 SUPPL-24 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20364slr024_lotrel_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20364slr024ltr.pdf
04/11/2006 SUPPL-23 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020364s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020364s023ltr.pdf
10/25/2002 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

09/20/2002 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

04/29/2002 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

12/12/2001 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

06/20/2002 SUPPL-16 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/020364-S016_Lotrel_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20364s016LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020364-s016_Lotrel.cfm
11/30/2001 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

08/29/2003 SUPPL-14 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20364slr014ltr.pdf
11/02/2000 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

05/10/2000 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/28/1999 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/18/1999 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/21/1998 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/16/1999 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-364-S008_Lotrel_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-364-S008_Lotrel_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-364S008_Lotrel.cfm
03/14/1997 SUPPL-7 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20364S007_Latrel.pdf
11/06/1995 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

11/17/1995 SUPPL-5 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

11/02/1995 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/15/1995 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

04/29/1996 SUPPL-2 Labeling

Label is not available on this site.

07/06/1995 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/21/2017 SUPPL-65 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020364s065lbl.pdf
05/18/2015 SUPPL-61 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020364s061lbl.pdf
04/22/2015 SUPPL-60 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020364s060lbl.pdf
12/31/2014 SUPPL-58 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020364s058lbl.pdf
10/05/2012 SUPPL-57 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020364s056s057lbl.pdf
10/05/2012 SUPPL-56 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020364s056s057lbl.pdf
01/19/2012 SUPPL-55 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020364s055lbl.pdf
10/28/2011 SUPPL-54 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020364s054lbl.pdf
06/20/2011 SUPPL-52 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020364s052lbl.pdf
01/04/2011 SUPPL-50 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020364s050lbl.pdf
03/29/2010 SUPPL-47 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020364s047lbl.pdf
12/22/2009 SUPPL-48 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020364s048lbl.pdf
10/28/2009 SUPPL-46 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020364s046lbl.pdf
08/31/2007 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020364s039lbl.pdf
04/11/2006 SUPPL-23 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020364s023lbl.pdf
07/02/2004 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20364slr024_lotrel_lbl.pdf
06/20/2002 SUPPL-16 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/020364-S016_Lotrel_lbl.pdf
06/16/1999 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-364-S008_Lotrel_prntlbl.pdf

LOTREL

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 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

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

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