Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020364
Company: SANDOZ
Company: SANDOZ
| 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 |
|---|---|---|---|---|---|
| 04/21/2021 | SUPPL-68 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020364Orig1s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020364Orig1s068ltr.pdf | |
| 02/10/2020 | SUPPL-66 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020364s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020364Orig1s066ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 04/21/2021 | SUPPL-68 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020364Orig1s068lbl.pdf | |
| 02/10/2020 | SUPPL-66 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020364s066lbl.pdf | |
| 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 |
| 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 | 077890 | WATSON LABS |
| LOTREL | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | EQ 2.5MG BASE;10MG | CAPSULE;ORAL | Prescription | Yes | AB | 020364 | SANDOZ |
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 |
| 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 | 077890 | WATSON LABS |
| LOTREL | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;10MG | CAPSULE;ORAL | Prescription | Yes | AB | 020364 | SANDOZ |
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 |
| 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 | 077890 | WATSON LABS |
| LOTREL | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;20MG | CAPSULE;ORAL | Prescription | Yes | AB | 020364 | SANDOZ |
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 |
| 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 | 077890 | WATSON LABS |
| LOTREL | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;20MG | CAPSULE;ORAL | Prescription | Yes | AB | 020364 | SANDOZ |
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 |
| 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 | 090364 | WATSON LABS INC |
| LOTREL | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | EQ 10MG BASE;40MG | CAPSULE;ORAL | Prescription | Yes | AB | 020364 | SANDOZ |
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 |
| 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 | 090364 | WATSON LABS INC |
| LOTREL | AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE | EQ 5MG BASE;40MG | CAPSULE;ORAL | Prescription | Yes | AB | 020364 | SANDOZ |