Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021990
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EXFORGE | AMLODIPINE BESYLATE; VALSARTAN | EQ 5MG BASE;160MG | TABLET;ORAL | Prescription | AB | Yes | No |
| EXFORGE | AMLODIPINE BESYLATE; VALSARTAN | EQ 10MG BASE;160MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| EXFORGE | AMLODIPINE BESYLATE; VALSARTAN | EQ 5MG BASE;320MG | TABLET;ORAL | Prescription | AB | Yes | No |
| EXFORGE | AMLODIPINE BESYLATE; VALSARTAN | EQ 10MG BASE;320MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 06/20/2007 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021990lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021990s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021990s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021990_exforge_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/07/2021 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021990s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021990Orig1s041ltr.pdf | |
| 06/12/2019 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021990s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021990Orig1s033ltr.pdf | |
| 02/12/2016 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/21/2015 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/28/2015 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021990s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021990Orig1s026ltr.pdf | |
| 05/22/2015 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/24/2014 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021990s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021990Orig1s024ltr.pdf | |
| 06/09/2014 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/17/2014 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021990s020s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021990Orig1s020,s021ltr.pdf | |
| 03/17/2014 | SUPPL-20 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021990Orig1s020,s021ltr.pdf |
| 11/28/2012 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021990s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021990Orig1s019ltr.pdf | |
| 09/28/2012 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021990s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021990Orig1s018ltr.pdf | |
| 01/18/2012 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021990s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021990s017,022314s012ltr.pdf | |
| 10/31/2011 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021990s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021990s016ltr.pdf | |
| 12/07/2011 | SUPPL-14 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021990s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021990s014ltr.pdf | |
| 05/31/2011 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021990s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021990s013ltr.pdf | |
| 03/30/2010 | SUPPL-7 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021990s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021990s007ltr.pdf | |
| 07/23/2008 | SUPPL-3 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021990s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021990s003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021990Orig1s003.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/07/2021 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021990s041lbl.pdf | |
| 06/12/2019 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021990s033lbl.pdf | |
| 07/28/2015 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021990s026lbl.pdf | |
| 09/24/2014 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021990s024lbl.pdf | |
| 03/17/2014 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021990s020s021lbl.pdf | |
| 11/28/2012 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021990s019lbl.pdf | |
| 09/28/2012 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021990s018lbl.pdf | |
| 01/18/2012 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021990s017lbl.pdf | |
| 12/07/2011 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021990s014lbl.pdf | |
| 10/31/2011 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021990s016lbl.pdf | |
| 05/31/2011 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021990s013lbl.pdf | |
| 03/30/2010 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021990s007lbl.pdf | |
| 07/23/2008 | SUPPL-3 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021990s003lbl.pdf | |
| 06/20/2007 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021990lbl.pdf |
EXFORGE
TABLET;ORAL; EQ 5MG BASE;160MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMLODIPINE BESYLATE AND VALSARTAN | AMLODIPINE BESYLATE; VALSARTAN | EQ 5MG BASE;160MG | TABLET;ORAL | Prescription | No | AB | 202713 | ALEMBIC |
| AMLODIPINE BESYLATE AND VALSARTAN | AMLODIPINE BESYLATE; VALSARTAN | EQ 5MG BASE;160MG | TABLET;ORAL | Prescription | No | AB | 206512 | AUROBINDO PHARMA |
| AMLODIPINE BESYLATE AND VALSARTAN | AMLODIPINE BESYLATE; VALSARTAN | EQ 5MG BASE;160MG | TABLET;ORAL | Prescription | No | AB | 205137 | HETERO LABS |
| AMLODIPINE BESYLATE AND VALSARTAN | AMLODIPINE BESYLATE; VALSARTAN | EQ 5MG BASE;160MG | TABLET;ORAL | Prescription | No | AB | 090245 | LUPIN |
| AMLODIPINE BESYLATE AND VALSARTAN | AMLODIPINE BESYLATE; VALSARTAN | EQ 5MG BASE;160MG | TABLET;ORAL | Prescription | No | AB | 090483 | MYLAN |
| AMLODIPINE BESYLATE AND VALSARTAN | AMLODIPINE BESYLATE; VALSARTAN | EQ 5MG BASE;160MG | TABLET;ORAL | Prescription | No | AB | 202829 | NOVEL LABS INC |
| AMLODIPINE BESYLATE AND VALSARTAN | AMLODIPINE BESYLATE; VALSARTAN | EQ 5MG BASE;160MG | TABLET;ORAL | Prescription | No | AB | 090011 | STRIDES PHARMA |
| EXFORGE | AMLODIPINE BESYLATE; VALSARTAN | EQ 5MG BASE;160MG | TABLET;ORAL | Prescription | Yes | AB | 021990 | NOVARTIS |
TABLET;ORAL; EQ 10MG BASE;160MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMLODIPINE BESYLATE AND VALSARTAN | AMLODIPINE BESYLATE; VALSARTAN | EQ 10MG BASE;160MG | TABLET;ORAL | Prescription | No | AB | 202713 | ALEMBIC |
| AMLODIPINE BESYLATE AND VALSARTAN | AMLODIPINE BESYLATE; VALSARTAN | EQ 10MG BASE;160MG | TABLET;ORAL | Prescription | No | AB | 206512 | AUROBINDO PHARMA |
| AMLODIPINE BESYLATE AND VALSARTAN | AMLODIPINE BESYLATE; VALSARTAN | EQ 10MG BASE;160MG | TABLET;ORAL | Prescription | No | AB | 205137 | HETERO LABS |
| AMLODIPINE BESYLATE AND VALSARTAN | AMLODIPINE BESYLATE; VALSARTAN | EQ 10MG BASE;160MG | TABLET;ORAL | Prescription | No | AB | 090245 | LUPIN |
| AMLODIPINE BESYLATE AND VALSARTAN | AMLODIPINE BESYLATE; VALSARTAN | EQ 10MG BASE;160MG | TABLET;ORAL | Prescription | No | AB | 090483 | MYLAN |
| AMLODIPINE BESYLATE AND VALSARTAN | AMLODIPINE BESYLATE; VALSARTAN | EQ 10MG BASE;160MG | TABLET;ORAL | Prescription | No | AB | 202829 | NOVEL LABS INC |
| AMLODIPINE BESYLATE AND VALSARTAN | AMLODIPINE BESYLATE; VALSARTAN | EQ 10MG BASE;160MG | TABLET;ORAL | Prescription | No | AB | 090011 | STRIDES PHARMA |
| EXFORGE | AMLODIPINE BESYLATE; VALSARTAN | EQ 10MG BASE;160MG | TABLET;ORAL | Prescription | Yes | AB | 021990 | NOVARTIS |
TABLET;ORAL; EQ 5MG BASE;320MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMLODIPINE BESYLATE AND VALSARTAN | AMLODIPINE BESYLATE; VALSARTAN | EQ 5MG BASE;320MG | TABLET;ORAL | Prescription | No | AB | 202713 | ALEMBIC |
| AMLODIPINE BESYLATE AND VALSARTAN | AMLODIPINE BESYLATE; VALSARTAN | EQ 5MG BASE;320MG | TABLET;ORAL | Prescription | No | AB | 206512 | AUROBINDO PHARMA |
| AMLODIPINE BESYLATE AND VALSARTAN | AMLODIPINE BESYLATE; VALSARTAN | EQ 5MG BASE;320MG | TABLET;ORAL | Prescription | No | AB | 205137 | HETERO LABS |
| AMLODIPINE BESYLATE AND VALSARTAN | AMLODIPINE BESYLATE; VALSARTAN | EQ 5MG BASE;320MG | TABLET;ORAL | Prescription | No | AB | 090245 | LUPIN |
| AMLODIPINE BESYLATE AND VALSARTAN | AMLODIPINE BESYLATE; VALSARTAN | EQ 5MG BASE;320MG | TABLET;ORAL | Prescription | No | AB | 090483 | MYLAN |
| AMLODIPINE BESYLATE AND VALSARTAN | AMLODIPINE BESYLATE; VALSARTAN | EQ 5MG BASE;320MG | TABLET;ORAL | Prescription | No | AB | 202829 | NOVEL LABS INC |
| AMLODIPINE BESYLATE AND VALSARTAN | AMLODIPINE BESYLATE; VALSARTAN | EQ 5MG BASE;320MG | TABLET;ORAL | Prescription | No | AB | 090011 | STRIDES PHARMA |
| EXFORGE | AMLODIPINE BESYLATE; VALSARTAN | EQ 5MG BASE;320MG | TABLET;ORAL | Prescription | Yes | AB | 021990 | NOVARTIS |
TABLET;ORAL; EQ 10MG BASE;320MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMLODIPINE BESYLATE AND VALSARTAN | AMLODIPINE BESYLATE; VALSARTAN | EQ 10MG BASE;320MG | TABLET;ORAL | Prescription | No | AB | 202713 | ALEMBIC |
| AMLODIPINE BESYLATE AND VALSARTAN | AMLODIPINE BESYLATE; VALSARTAN | EQ 10MG BASE;320MG | TABLET;ORAL | Prescription | No | AB | 206512 | AUROBINDO PHARMA |
| AMLODIPINE BESYLATE AND VALSARTAN | AMLODIPINE BESYLATE; VALSARTAN | EQ 10MG BASE;320MG | TABLET;ORAL | Prescription | No | AB | 205137 | HETERO LABS |
| AMLODIPINE BESYLATE AND VALSARTAN | AMLODIPINE BESYLATE; VALSARTAN | EQ 10MG BASE;320MG | TABLET;ORAL | Prescription | No | AB | 090245 | LUPIN |
| AMLODIPINE BESYLATE AND VALSARTAN | AMLODIPINE BESYLATE; VALSARTAN | EQ 10MG BASE;320MG | TABLET;ORAL | Prescription | No | AB | 090483 | MYLAN |
| AMLODIPINE BESYLATE AND VALSARTAN | AMLODIPINE BESYLATE; VALSARTAN | EQ 10MG BASE;320MG | TABLET;ORAL | Prescription | No | AB | 202829 | NOVEL LABS INC |
| AMLODIPINE BESYLATE AND VALSARTAN | AMLODIPINE BESYLATE; VALSARTAN | EQ 10MG BASE;320MG | TABLET;ORAL | Prescription | No | AB | 090011 | STRIDES PHARMA |
| EXFORGE | AMLODIPINE BESYLATE; VALSARTAN | EQ 10MG BASE;320MG | TABLET;ORAL | Prescription | Yes | AB | 021990 | NOVARTIS |