Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020758
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HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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HYDROCHLOROTHIAZIDE; IRBESARTAN 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
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
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 PHARMS LTD
IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;150MG TABLET;ORAL Prescription No AB 201505 APOTEX INC
IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;150MG TABLET;ORAL Prescription No AB 203036 ATLAS PHARMS LLC
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 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 077969 MYLAN PHARMS INC
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
IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;150MG TABLET;ORAL Prescription No AB 207018 UNICHEM LABS LTD
IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;150MG TABLET;ORAL Prescription No AB 090351 WEST-WARD PHARMS INT

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 PHARMS LTD
IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;300MG TABLET;ORAL Prescription No AB 201505 APOTEX INC
IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;300MG TABLET;ORAL Prescription No AB 203036 ATLAS PHARMS LLC
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 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 077969 MYLAN PHARMS INC
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
IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;300MG TABLET;ORAL Prescription No AB 207018 UNICHEM LABS LTD
IRBESARTAN AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; IRBESARTAN 12.5MG;300MG TABLET;ORAL Prescription No AB 090351 WEST-WARD PHARMS INT

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