Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022314
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EXFORGE HCT AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 5MG;12.5MG;160MG TABLET;ORAL Prescription AB Yes No
EXFORGE HCT AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 5MG;25MG;160MG TABLET;ORAL Prescription AB Yes No
EXFORGE HCT AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10MG;12.5MG;160MG TABLET;ORAL Prescription AB Yes No
EXFORGE HCT AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10MG;25MG;160MG TABLET;ORAL Prescription AB Yes No
EXFORGE HCT AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10MG;25MG;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
04/30/2009 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022314lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022314s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022314s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022314s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/12/2019 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022314s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022314Orig1s027ltr.pdf
02/12/2016 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

07/28/2015 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022314s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022314Orig1s020ltr.pdf
09/24/2014 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022314s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022314Orig1s019ltr.pdf
06/09/2014 SUPPL-17 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022314s017lbl.pdf
03/17/2014 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022314s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022314Orig1s015,s016ltr.pdf
03/17/2014 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022314s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022314Orig1s015,s016ltr.pdf
11/28/2012 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022314s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022314Orig1s014ltr.pdf
09/28/2012 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022314s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022314Orig1s013ltr.pdf
01/18/2012 SUPPL-12 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021990s017,022314s012ltr.pdf
10/31/2011 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022314s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022314s011ltr.pdf
02/16/2012 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022314s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022314s009ltr.pdf
12/07/2011 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022314s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022314s007ltr.pdf
06/03/2011 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022314s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022314s005ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/12/2019 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022314s027lbl.pdf
07/28/2015 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022314s020lbl.pdf
09/24/2014 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022314s019lbl.pdf
06/09/2014 SUPPL-17 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022314s017lbl.pdf
03/17/2014 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022314s015s016lbl.pdf
03/17/2014 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022314s015s016lbl.pdf
11/28/2012 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022314s014lbl.pdf
09/28/2012 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022314s013lbl.pdf
02/16/2012 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022314s009lbl.pdf
12/07/2011 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022314s007lbl.pdf
10/31/2011 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022314s011lbl.pdf
06/03/2011 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022314s005lbl.pdf
04/30/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022314lbl.pdf

EXFORGE HCT

TABLET;ORAL; 5MG;12.5MG;160MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 5MG;12.5MG;160MG TABLET;ORAL Prescription No AB 206180 AUROBINDO PHARMA LTD
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 5MG;12.5MG;160MG TABLET;ORAL Prescription No AB 200797 LUPIN LTD
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 5MG;12.5MG;160MG TABLET;ORAL Prescription No AB 201087 PAR PHARM
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 5MG;12.5MG;160MG TABLET;ORAL Prescription No AB 201593 TORRENT
EXFORGE HCT AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 5MG;12.5MG;160MG TABLET;ORAL Prescription Yes AB 022314 NOVARTIS

TABLET;ORAL; 5MG;25MG;160MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 5MG;25MG;160MG TABLET;ORAL Prescription No AB 206180 AUROBINDO PHARMA LTD
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 5MG;25MG;160MG TABLET;ORAL Prescription No AB 200797 LUPIN LTD
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 5MG;25MG;160MG TABLET;ORAL Prescription No AB 201087 PAR PHARM
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 5MG;25MG;160MG TABLET;ORAL Prescription No AB 201593 TORRENT
EXFORGE HCT AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 5MG;25MG;160MG TABLET;ORAL Prescription Yes AB 022314 NOVARTIS

TABLET;ORAL; 10MG;12.5MG;160MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10MG;12.5MG;160MG TABLET;ORAL Prescription No AB 206180 AUROBINDO PHARMA LTD
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10MG;12.5MG;160MG TABLET;ORAL Prescription No AB 200797 LUPIN LTD
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10MG;12.5MG;160MG TABLET;ORAL Prescription No AB 201087 PAR PHARM
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10MG;12.5MG;160MG TABLET;ORAL Prescription No AB 201593 TORRENT
EXFORGE HCT AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10MG;12.5MG;160MG TABLET;ORAL Prescription Yes AB 022314 NOVARTIS

TABLET;ORAL; 10MG;25MG;160MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10MG;25MG;160MG TABLET;ORAL Prescription No AB 206180 AUROBINDO PHARMA LTD
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10MG;25MG;160MG TABLET;ORAL Prescription No AB 200797 LUPIN LTD
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10MG;25MG;160MG TABLET;ORAL Prescription No AB 201087 PAR PHARM
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10MG;25MG;160MG TABLET;ORAL Prescription No AB 201593 TORRENT
EXFORGE HCT AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10MG;25MG;160MG TABLET;ORAL Prescription Yes AB 022314 NOVARTIS

TABLET;ORAL; 10MG;25MG;320MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10MG;25MG;320MG TABLET;ORAL Prescription No AB 206180 AUROBINDO PHARMA LTD
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10MG;25MG;320MG TABLET;ORAL Prescription No AB 200797 LUPIN LTD
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10MG;25MG;320MG TABLET;ORAL Prescription No AB 201087 PAR PHARM
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10MG;25MG;320MG TABLET;ORAL Prescription No AB 201593 TORRENT
EXFORGE HCT AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN 10MG;25MG;320MG TABLET;ORAL Prescription Yes AB 022314 NOVARTIS

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