Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022314
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EXFORGE HCT | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 5MG BASE;12.5MG;160MG | TABLET;ORAL | Prescription | AB | Yes | No |
| EXFORGE HCT | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 5MG BASE;25MG;160MG | TABLET;ORAL | Prescription | AB | Yes | No |
| EXFORGE HCT | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 10MG BASE;12.5MG;160MG | TABLET;ORAL | Prescription | AB | Yes | No |
| EXFORGE HCT | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 10MG BASE;25MG;160MG | TABLET;ORAL | Prescription | AB | Yes | No |
| EXFORGE HCT | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 10MG BASE;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 |
|---|---|---|---|---|---|
| 09/26/2022 | SUPPL-38 | Manufacturing (CMC)-Facility |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022314Orig1s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022314Orig1s038ltr.pdf | |
| 02/22/2021 | SUPPL-36 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022314Orig1s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022314Orig1s036ltr.pdf | |
| 08/20/2020 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022314s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022314Orig1s035ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 09/26/2022 | SUPPL-38 | Manufacturing (CMC)-Facility | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022314Orig1s038lbl.pdf | |
| 02/22/2021 | SUPPL-36 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022314Orig1s036lbl.pdf | |
| 08/20/2020 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022314s035lbl.pdf | |
| 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; EQ 5MG BASE;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 | EQ 5MG BASE;12.5MG;160MG | TABLET;ORAL | Prescription | No | AB | 206180 | AUROBINDO PHARMA |
| AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 5MG BASE;12.5MG;160MG | TABLET;ORAL | Prescription | No | AB | 200797 | LUPIN LTD |
| AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 5MG BASE;12.5MG;160MG | TABLET;ORAL | Prescription | No | AB | 201087 | STRIDES PHARMA |
| EXFORGE HCT | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 5MG BASE;12.5MG;160MG | TABLET;ORAL | Prescription | Yes | AB | 022314 | NOVARTIS |
TABLET;ORAL; EQ 5MG BASE;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 | EQ 5MG BASE;25MG;160MG | TABLET;ORAL | Prescription | No | AB | 206180 | AUROBINDO PHARMA |
| AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 5MG BASE;25MG;160MG | TABLET;ORAL | Prescription | No | AB | 200797 | LUPIN LTD |
| AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 5MG BASE;25MG;160MG | TABLET;ORAL | Prescription | No | AB | 201087 | STRIDES PHARMA |
| EXFORGE HCT | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 5MG BASE;25MG;160MG | TABLET;ORAL | Prescription | Yes | AB | 022314 | NOVARTIS |
TABLET;ORAL; EQ 10MG BASE;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 | EQ 10MG BASE;12.5MG;160MG | TABLET;ORAL | Prescription | No | AB | 206180 | AUROBINDO PHARMA |
| AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 10MG BASE;12.5MG;160MG | TABLET;ORAL | Prescription | No | AB | 200797 | LUPIN LTD |
| AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 10MG BASE;12.5MG;160MG | TABLET;ORAL | Prescription | No | AB | 201087 | STRIDES PHARMA |
| EXFORGE HCT | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 10MG BASE;12.5MG;160MG | TABLET;ORAL | Prescription | Yes | AB | 022314 | NOVARTIS |
TABLET;ORAL; EQ 10MG BASE;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 | EQ 10MG BASE;25MG;160MG | TABLET;ORAL | Prescription | No | AB | 206180 | AUROBINDO PHARMA |
| AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 10MG BASE;25MG;160MG | TABLET;ORAL | Prescription | No | AB | 200797 | LUPIN LTD |
| AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 10MG BASE;25MG;160MG | TABLET;ORAL | Prescription | No | AB | 201087 | STRIDES PHARMA |
| EXFORGE HCT | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 10MG BASE;25MG;160MG | TABLET;ORAL | Prescription | Yes | AB | 022314 | NOVARTIS |
TABLET;ORAL; EQ 10MG BASE;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 | EQ 10MG BASE;25MG;320MG | TABLET;ORAL | Prescription | No | AB | 206180 | AUROBINDO PHARMA |
| AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 10MG BASE;25MG;320MG | TABLET;ORAL | Prescription | No | AB | 200797 | LUPIN LTD |
| AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 10MG BASE;25MG;320MG | TABLET;ORAL | Prescription | No | AB | 201087 | STRIDES PHARMA |
| EXFORGE HCT | AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN | EQ 10MG BASE;25MG;320MG | TABLET;ORAL | Prescription | Yes | AB | 022314 | NOVARTIS |