Drugs@FDA: FDA-Approved Drugs
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| HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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| HYDROCHLOROTHIAZIDE; IRBESARTAN | 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
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.cfm |
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 |
---|---|---|---|---|---|
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 | 201524 | LUPIN LTD |
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 | 201524 | LUPIN LTD |
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 |