Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020757
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
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
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 200832 APOTEX INC
IRBESARTAN IRBESARTAN 75MG TABLET;ORAL Prescription No AB 203081 AUROBINDO PHARMA LTD
IRBESARTAN IRBESARTAN 75MG TABLET;ORAL Prescription No AB 077205 CIPLA LTD
IRBESARTAN IRBESARTAN 75MG TABLET;ORAL Prescription No AB 203161 DR REDDYS LABS LTD
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 200461 MYLAN PHARMS INC
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 LABS LTD
IRBESARTAN IRBESARTAN 75MG TABLET;ORAL Prescription No AB 090201 WEST-WARD PHARMS INT
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 200832 APOTEX INC
IRBESARTAN IRBESARTAN 150MG TABLET;ORAL Prescription No AB 203081 AUROBINDO PHARMA LTD
IRBESARTAN IRBESARTAN 150MG TABLET;ORAL Prescription No AB 077205 CIPLA LTD
IRBESARTAN IRBESARTAN 150MG TABLET;ORAL Prescription No AB 203161 DR REDDYS LABS LTD
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 200461 MYLAN PHARMS INC
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 LABS LTD
IRBESARTAN IRBESARTAN 150MG TABLET;ORAL Prescription No AB 090201 WEST-WARD PHARMS INT
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 200832 APOTEX INC
IRBESARTAN IRBESARTAN 300MG TABLET;ORAL Prescription No AB 203081 AUROBINDO PHARMA LTD
IRBESARTAN IRBESARTAN 300MG TABLET;ORAL Prescription No AB 077205 CIPLA LTD
IRBESARTAN IRBESARTAN 300MG TABLET;ORAL Prescription No AB 203161 DR REDDYS LABS LTD
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 200461 MYLAN PHARMS INC
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 LABS LTD
IRBESARTAN IRBESARTAN 300MG TABLET;ORAL Prescription No AB 090201 WEST-WARD PHARMS INT
IRBESARTAN IRBESARTAN 300MG TABLET;ORAL Prescription No AB 079213 ZYDUS PHARMS USA INC

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