Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020758
Company: SANOFI AVENTIS US
Company: SANOFI AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AVALIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| AVALIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;150MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| AVALIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;300MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| AVALIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 09/30/1997 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020757_020758_toc.html |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/01/2025 | SUPPL-87 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020758s087lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/020758Orig1s087ltr.pdf | |
| 05/11/2021 | SUPPL-81 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020758s081lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020758Orig1s081ltr.pdf | |
| 09/10/2021 | SUPPL-80 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020758s080lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020758Orig1s080ltr.pdf | |
| 08/20/2020 | SUPPL-79 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020758s079lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020758s079ltr.pdf | |
| 12/15/2020 | SUPPL-76 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020758s076lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020758Orig1s076ltr.pdf | |
| 07/20/2018 | SUPPL-73 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020758s073lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020758Orig1s073Ltr.pdf | |
| 07/10/2017 | SUPPL-72 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020758s072lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020758Orig1s072ltr.pdf | |
| 02/05/2016 | SUPPL-70 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020758s070lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020758Orig1s070ltr.pdf | |
| 05/28/2014 | SUPPL-67 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020758s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020758Orig1s067ltr.pdf | |
| 10/26/2012 | SUPPL-64 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020758s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020758Orig1s064ltr.pdf | |
| 01/18/2012 | SUPPL-62 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020758s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020758s062ltr.pdf | |
| 02/09/2012 | SUPPL-60 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020758s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020758s060ltr.pdf | |
| 06/06/2011 | SUPPL-59 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020758s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020758s058,s059ltr.pdf | |
| 06/06/2011 | SUPPL-58 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020758s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020758s058,s059ltr.pdf | |
| 09/07/2010 | SUPPL-50 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020758s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020758s050ltr.pdf | |
| 11/16/2007 | SUPPL-37 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020758s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020758s037ltr.pdf | |
| 04/21/2006 | SUPPL-36 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020758s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020758s036LTR.pdf | |
| 11/21/2005 | SUPPL-35 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020758s035ltr.pdf |
| 03/15/2005 | SUPPL-32 | Manufacturing (CMC)-Formulation |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20758s032ltr.pdf |
| 10/29/2004 | SUPPL-31 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-758s031_Avalide.pdf | |
| 07/21/2004 | SUPPL-30 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-758s030_Avalide.pdf | |
| 01/02/2004 | SUPPL-29 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-757s030_Avapro.PDF | |
| 10/10/2003 | SUPPL-28 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-757s029_Avapro_P1.PDF | |
| 05/01/2003 | SUPPL-23 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-757s024_Avapro_P1.PDF | |
| 06/07/2001 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/06/2001 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/21/2001 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/20/2000 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 05/10/2000 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/09/2000 | SUPPL-16 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20758-s016_avalide.pdf |
| 08/01/2000 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/28/2000 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/26/2001 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 08/23/2000 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/20/1999 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 03/16/1999 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/16/1999 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/21/1999 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/14/1998 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 07/15/1998 | SUPPL-6 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 09/03/1998 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/06/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/31/1998 | SUPPL-3 | Manufacturing (CMC)-Formulation |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20758S003.html |
| 01/30/1998 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/30/1998 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/01/2025 | SUPPL-87 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020758s087lbl.pdf | |
| 09/10/2021 | SUPPL-80 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020758s080lbl.pdf | |
| 05/11/2021 | SUPPL-81 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020758s081lbl.pdf | |
| 12/15/2020 | SUPPL-76 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020758s076lbl.pdf | |
| 08/20/2020 | SUPPL-79 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020758s079lbl.pdf | |
| 07/20/2018 | SUPPL-73 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020758s073lbl.pdf | |
| 07/10/2017 | SUPPL-72 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020758s072lbl.pdf | |
| 02/05/2016 | SUPPL-70 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020758s070lbl.pdf | |
| 05/28/2014 | SUPPL-67 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020758s067lbl.pdf | |
| 10/26/2012 | SUPPL-64 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020758s064lbl.pdf | |
| 02/09/2012 | SUPPL-60 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020758s060lbl.pdf | |
| 01/18/2012 | SUPPL-62 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020758s062lbl.pdf | |
| 06/06/2011 | SUPPL-59 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020758s059lbl.pdf | |
| 06/06/2011 | SUPPL-58 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020758s058lbl.pdf | |
| 09/07/2010 | SUPPL-50 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020758s050lbl.pdf | |
| 11/16/2007 | SUPPL-37 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020758s037lbl.pdf | |
| 04/21/2006 | SUPPL-36 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020758s036lbl.pdf |
AVALIDE
TABLET;ORAL; 12.5MG;150MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AVALIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;150MG | TABLET;ORAL | Prescription | Yes | AB | 020758 | SANOFI AVENTIS US |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;150MG | TABLET;ORAL | Prescription | No | AB | 091370 | ALEMBIC |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;150MG | TABLET;ORAL | Prescription | No | AB | 203630 | AUROBINDO PHARMA LTD |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;150MG | TABLET;ORAL | Prescription | No | AB | 203500 | DR REDDYS LABS LTD |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;150MG | TABLET;ORAL | Prescription | No | AB | 090351 | HIKMA |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;150MG | TABLET;ORAL | Prescription | No | AB | 207896 | HISUN PHARM HANGZHOU |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;150MG | TABLET;ORAL | Prescription | No | AB | 202414 | MACLEODS PHARMS LTD |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;150MG | TABLET;ORAL | Prescription | No | AB | 203072 | PRINSTON INC |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;150MG | TABLET;ORAL | Prescription | No | AB | 077446 | SANDOZ |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;150MG | TABLET;ORAL | Prescription | No | AB | 077369 | TEVA |
TABLET;ORAL; 12.5MG;300MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AVALIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;300MG | TABLET;ORAL | Prescription | Yes | AB | 020758 | SANOFI AVENTIS US |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;300MG | TABLET;ORAL | Prescription | No | AB | 091370 | ALEMBIC |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;300MG | TABLET;ORAL | Prescription | No | AB | 203630 | AUROBINDO PHARMA LTD |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;300MG | TABLET;ORAL | Prescription | No | AB | 203500 | DR REDDYS LABS LTD |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;300MG | TABLET;ORAL | Prescription | No | AB | 090351 | HIKMA |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;300MG | TABLET;ORAL | Prescription | No | AB | 207896 | HISUN PHARM HANGZHOU |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;300MG | TABLET;ORAL | Prescription | No | AB | 202414 | MACLEODS PHARMS LTD |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;300MG | TABLET;ORAL | Prescription | No | AB | 203072 | PRINSTON INC |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;300MG | TABLET;ORAL | Prescription | No | AB | 077446 | SANDOZ |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;300MG | TABLET;ORAL | Prescription | No | AB | 077369 | TEVA |