Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021990
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
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
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 PHARMS LTD
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 5MG BASE;160MG TABLET;ORAL Prescription No AB 206512 AUROBINDO PHARMA LTD
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 5MG BASE;160MG TABLET;ORAL Prescription No AB 205137 INVAGEN PHARMS
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 PAR PHARM INC
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 5MG BASE;160MG TABLET;ORAL Prescription No AB 202377 TORRENT
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 PHARMS LTD
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;160MG TABLET;ORAL Prescription No AB 206512 AUROBINDO PHARMA LTD
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;160MG TABLET;ORAL Prescription No AB 205137 INVAGEN PHARMS
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 PAR PHARM INC
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;160MG TABLET;ORAL Prescription No AB 202377 TORRENT
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 PHARMS LTD
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 5MG BASE;320MG TABLET;ORAL Prescription No AB 206512 AUROBINDO PHARMA LTD
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 5MG BASE;320MG TABLET;ORAL Prescription No AB 205137 INVAGEN PHARMS
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 PAR PHARM INC
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 5MG BASE;320MG TABLET;ORAL Prescription No AB 202377 TORRENT
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 PHARMS LTD
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;320MG TABLET;ORAL Prescription No AB 206512 AUROBINDO PHARMA LTD
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;320MG TABLET;ORAL Prescription No AB 205137 INVAGEN PHARMS
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 PAR PHARM INC
AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;320MG TABLET;ORAL Prescription No AB 202377 TORRENT
EXFORGE AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;320MG TABLET;ORAL Prescription Yes AB 021990 NOVARTIS

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