Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020757
Company: SANOFI AVENTIS US
Company: SANOFI AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AVAPRO | IRBESARTAN | 75MG | TABLET;ORAL | Prescription | AB | Yes | No |
| AVAPRO | IRBESARTAN | 150MG | TABLET;ORAL | Prescription | AB | Yes | No |
| AVAPRO | IRBESARTAN | 300MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/30/1997 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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-75 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020757s075lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020757Orig1s075ltr.pdf | |
| 09/10/2021 | SUPPL-74 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020757s074lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020757Orig1s074ltr.pdf | |
| 12/15/2020 | SUPPL-71 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020757s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020757Orig1s071ltr.pdf | |
| 07/20/2018 | SUPPL-69 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020757s069lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020757Orig1s069Ltr.pdf | |
| 02/05/2016 | SUPPL-67 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020757s059s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020757Orig1s059,s067ltr.pdf | |
| 01/05/2015 | SUPPL-65 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/28/2014 | SUPPL-64 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020757s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020757Orig1s064ltr.pdf | |
| 10/10/2013 | SUPPL-63 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/28/2013 | SUPPL-61 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/12/2012 | SUPPL-60 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020757s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020757Orig1s060ltr.pdf | |
| 02/05/2016 | SUPPL-59 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020757s059s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020757Orig1s059,s067ltr.pdf | |
| 01/18/2012 | SUPPL-58 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020757s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020757Orig1s058ltr.pdf | |
| 12/08/2011 | SUPPL-56 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020757s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020757s056ltr.pdf | |
| 08/01/2011 | SUPPL-55 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020757s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020757s055ltr.pdf | |
| 03/16/2006 | SUPPL-39 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020757s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020757s039ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020757_s039_avapro.pdf | |
| 04/21/2006 | SUPPL-38 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020757s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020757s038LTR.pdf | |
| 11/21/2005 | SUPPL-37 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020757s037ltr.pdf |
| 10/29/2004 | SUPPL-33 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-757s033_Avapro.PDF | |
| 07/21/2004 | SUPPL-32 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-757s032_Avapro.PDF | |
| 05/20/2004 | SUPPL-31 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-757s031_Avapro.PDF | |
| 01/02/2004 | SUPPL-30 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/20-757s030_Avapro.PDF | |
| 09/09/2003 | SUPPL-28 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-757s028_Avapro_P2.PDF | |
| 10/09/2003 | SUPPL-27 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-757s027_Avapro.PDF | |
| 05/21/2003 | SUPPL-26 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-757s026_Avapro.PDF | |
| 03/21/2003 | SUPPL-25 |
Label is not available on this site. |
|||
| 05/01/2003 | SUPPL-24 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-757s024_Avapro_P1.PDF | |
| 03/21/2003 | SUPPL-23 |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-757s023_Avapro_P1.PDF | |
| 07/19/2002 | SUPPL-22 | Manufacturing (CMC) |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20757scm022ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-757s022_Avapro.PDF |
| 09/17/2002 | SUPPL-21 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20757s21lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20757se1-021ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-757s021_Avapro.cfm | |
| 06/07/2001 | SUPPL-20 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-757s020_Avapro.PDF |
| 03/06/2001 | SUPPL-19 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-757s019_Avapro.PDF |
| 02/02/2001 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-757s018_Avapro_P1.pdf |
| 09/20/2000 | SUPPL-17 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-757s017_Avapro.PDF |
| 05/10/2000 | SUPPL-16 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20757-s016_avapro.pdf |
| 05/09/2000 | SUPPL-15 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20757-s015_avapro.pdf |
| 05/26/2001 | SUPPL-14 | Efficacy-New Patient Population |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-757S014_Avapro.pdf |
| 08/01/2000 | SUPPL-13 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-757s013_Avapro.pdf |
| 04/28/2000 | SUPPL-12 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-757s012_Avapro.PDF |
| 09/26/2001 | SUPPL-11 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-757s011_Avapro.PDF |
| 08/23/2000 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/02/1999 | SUPPL-9 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-757s009_Avapro.PDF |
| 03/16/1999 | SUPPL-8 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-757s008_Avapro.PDF |
| 03/16/1999 | SUPPL-7 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-757s007_Avapro.PDF |
| 12/08/1998 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 09/03/1998 | SUPPL-5 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-757s005_Avapro.PDF |
| 04/06/1998 | SUPPL-4 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-757s004_Avapro.PDF |
| 01/30/1998 | SUPPL-3 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 01/30/1998 | SUPPL-2 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-757s002_Avapro.PDF |
| 11/10/1997 | SUPPL-1 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20-757s001_Avapro.PDF |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/10/2021 | SUPPL-74 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020757s074lbl.pdf | |
| 05/11/2021 | SUPPL-75 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020757s075lbl.pdf | |
| 12/15/2020 | SUPPL-71 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020757s071lbl.pdf | |
| 07/20/2018 | SUPPL-69 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020757s069lbl.pdf | |
| 02/05/2016 | SUPPL-67 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020757s059s067lbl.pdf | |
| 02/05/2016 | SUPPL-59 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020757s059s067lbl.pdf | |
| 05/28/2014 | SUPPL-64 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020757s064lbl.pdf | |
| 09/12/2012 | SUPPL-60 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020757s060lbl.pdf | |
| 01/18/2012 | SUPPL-58 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020757s058lbl.pdf | |
| 12/08/2011 | SUPPL-56 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020757s056lbl.pdf | |
| 08/01/2011 | SUPPL-55 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020757s055lbl.pdf | |
| 04/21/2006 | SUPPL-38 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020757s038lbl.pdf | |
| 03/16/2006 | SUPPL-39 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020757s039lbl.pdf | |
| 09/17/2002 | SUPPL-21 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20757s21lbl.pdf |
AVAPRO
TABLET;ORAL; 75MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AVAPRO | IRBESARTAN | 75MG | TABLET;ORAL | Prescription | Yes | AB | 020757 | SANOFI AVENTIS US |
| IRBESARTAN | IRBESARTAN | 75MG | TABLET;ORAL | Prescription | No | AB | 091236 | ALEMBIC PHARMS LTD |
| IRBESARTAN | IRBESARTAN | 75MG | TABLET;ORAL | Prescription | No | AB | 204740 | AMNEAL PHARMS |
| IRBESARTAN | IRBESARTAN | 75MG | TABLET;ORAL | Prescription | No | AB | 203081 | AUROBINDO PHARMA LTD |
| IRBESARTAN | IRBESARTAN | 75MG | TABLET;ORAL | Prescription | No | AB | 077205 | CHARTWELL MOLECULAR |
| IRBESARTAN | IRBESARTAN | 75MG | TABLET;ORAL | Prescription | No | AB | 202910 | HETERO LABS LTD V |
| IRBESARTAN | IRBESARTAN | 75MG | TABLET;ORAL | Prescription | No | AB | 206194 | HISUN PHARM HANGZHOU |
| IRBESARTAN | IRBESARTAN | 75MG | TABLET;ORAL | Prescription | No | AB | 203534 | JUBILANT GENERICS |
| IRBESARTAN | IRBESARTAN | 75MG | TABLET;ORAL | Prescription | No | AB | 201531 | LUPIN LTD |
| IRBESARTAN | IRBESARTAN | 75MG | TABLET;ORAL | Prescription | No | AB | 202254 | MACLEODS PHARMS LTD |
| IRBESARTAN | IRBESARTAN | 75MG | TABLET;ORAL | Prescription | No | AB | 203071 | PRINSTON INC |
| IRBESARTAN | IRBESARTAN | 75MG | TABLET;ORAL | Prescription | No | AB | 077466 | SANDOZ |
| IRBESARTAN | IRBESARTAN | 75MG | TABLET;ORAL | Prescription | No | AB | 204774 | SCIEGEN PHARMS INC |
| IRBESARTAN | IRBESARTAN | 75MG | TABLET;ORAL | Prescription | No | AB | 077159 | TEVA PHARMS |
| IRBESARTAN | IRBESARTAN | 75MG | TABLET;ORAL | Prescription | No | AB | 203020 | UNICHEM |
| IRBESARTAN | IRBESARTAN | 75MG | TABLET;ORAL | Prescription | No | AB | 079213 | ZYDUS PHARMS USA INC |
TABLET;ORAL; 150MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AVAPRO | IRBESARTAN | 150MG | TABLET;ORAL | Prescription | Yes | AB | 020757 | SANOFI AVENTIS US |
| IRBESARTAN | IRBESARTAN | 150MG | TABLET;ORAL | Prescription | No | AB | 091236 | ALEMBIC PHARMS LTD |
| IRBESARTAN | IRBESARTAN | 150MG | TABLET;ORAL | Prescription | No | AB | 204740 | AMNEAL PHARMS |
| IRBESARTAN | IRBESARTAN | 150MG | TABLET;ORAL | Prescription | No | AB | 203081 | AUROBINDO PHARMA LTD |
| IRBESARTAN | IRBESARTAN | 150MG | TABLET;ORAL | Prescription | No | AB | 077205 | CHARTWELL MOLECULAR |
| IRBESARTAN | IRBESARTAN | 150MG | TABLET;ORAL | Prescription | No | AB | 202910 | HETERO LABS LTD V |
| IRBESARTAN | IRBESARTAN | 150MG | TABLET;ORAL | Prescription | No | AB | 206194 | HISUN PHARM HANGZHOU |
| IRBESARTAN | IRBESARTAN | 150MG | TABLET;ORAL | Prescription | No | AB | 203534 | JUBILANT GENERICS |
| IRBESARTAN | IRBESARTAN | 150MG | TABLET;ORAL | Prescription | No | AB | 201531 | LUPIN LTD |
| IRBESARTAN | IRBESARTAN | 150MG | TABLET;ORAL | Prescription | No | AB | 202254 | MACLEODS PHARMS LTD |
| IRBESARTAN | IRBESARTAN | 150MG | TABLET;ORAL | Prescription | No | AB | 203071 | PRINSTON INC |
| IRBESARTAN | IRBESARTAN | 150MG | TABLET;ORAL | Prescription | No | AB | 077466 | SANDOZ |
| IRBESARTAN | IRBESARTAN | 150MG | TABLET;ORAL | Prescription | No | AB | 204774 | SCIEGEN PHARMS INC |
| IRBESARTAN | IRBESARTAN | 150MG | TABLET;ORAL | Prescription | No | AB | 077159 | TEVA PHARMS |
| IRBESARTAN | IRBESARTAN | 150MG | TABLET;ORAL | Prescription | No | AB | 203020 | UNICHEM |
| IRBESARTAN | IRBESARTAN | 150MG | TABLET;ORAL | Prescription | No | AB | 079213 | ZYDUS PHARMS USA INC |
TABLET;ORAL; 300MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AVAPRO | IRBESARTAN | 300MG | TABLET;ORAL | Prescription | Yes | AB | 020757 | SANOFI AVENTIS US |
| IRBESARTAN | IRBESARTAN | 300MG | TABLET;ORAL | Prescription | No | AB | 091236 | ALEMBIC PHARMS LTD |
| IRBESARTAN | IRBESARTAN | 300MG | TABLET;ORAL | Prescription | No | AB | 204740 | AMNEAL PHARMS |
| IRBESARTAN | IRBESARTAN | 300MG | TABLET;ORAL | Prescription | No | AB | 203081 | AUROBINDO PHARMA LTD |
| IRBESARTAN | IRBESARTAN | 300MG | TABLET;ORAL | Prescription | No | AB | 077205 | CHARTWELL MOLECULAR |
| IRBESARTAN | IRBESARTAN | 300MG | TABLET;ORAL | Prescription | No | AB | 202910 | HETERO LABS LTD V |
| IRBESARTAN | IRBESARTAN | 300MG | TABLET;ORAL | Prescription | No | AB | 206194 | HISUN PHARM HANGZHOU |
| IRBESARTAN | IRBESARTAN | 300MG | TABLET;ORAL | Prescription | No | AB | 203534 | JUBILANT GENERICS |
| IRBESARTAN | IRBESARTAN | 300MG | TABLET;ORAL | Prescription | No | AB | 201531 | LUPIN LTD |
| IRBESARTAN | IRBESARTAN | 300MG | TABLET;ORAL | Prescription | No | AB | 202254 | MACLEODS PHARMS LTD |
| IRBESARTAN | IRBESARTAN | 300MG | TABLET;ORAL | Prescription | No | AB | 203071 | PRINSTON INC |
| IRBESARTAN | IRBESARTAN | 300MG | TABLET;ORAL | Prescription | No | AB | 077466 | SANDOZ |
| IRBESARTAN | IRBESARTAN | 300MG | TABLET;ORAL | Prescription | No | AB | 204774 | SCIEGEN PHARMS INC |
| IRBESARTAN | IRBESARTAN | 300MG | TABLET;ORAL | Prescription | No | AB | 077159 | TEVA PHARMS |
| IRBESARTAN | IRBESARTAN | 300MG | TABLET;ORAL | Prescription | No | AB | 203020 | UNICHEM |
| IRBESARTAN | IRBESARTAN | 300MG | TABLET;ORAL | Prescription | No | AB | 079213 | ZYDUS PHARMS USA INC |