NDA 020758

SANOFI AVENTIS US

FDA Drug Application

Application #020758

Documents

• Letter: 2005-03-18
• Letter: 2006-04-25
• Letter: 2011-06-09
• Letter: 2012-10-29
• Letter: 2014-06-02
• Label: 2007-11-19
• Label: 2012-10-26
• Review: 2009-09-01
• Review: 1998-08-31
• Review: 2004-05-27
• Review: 2005-05-03
• Review: 2005-04-27
• Letter: 2005-11-30
• Letter: 2007-11-19
• Letter: 2010-09-09
• Letter: 2011-06-09
• Letter: 2012-02-13
• Letter: 2012-01-23
• Letter: 2016-02-09
• Label: 2006-04-25
• Label: 2010-09-10
• Label: 2011-06-06
• Label: 2011-06-06
• Label: 2012-02-17
• Label: 2012-01-23
• Label: 2014-05-30
• Label: 2016-02-18
• Review: 2005-05-05
• Review: 2005-05-03
• Review: 2005-04-27
• Other: 2005-05-05
• Other: 2005-05-03
• Label: 2017-07-13
• Letter: 2017-07-13
• Letter: 2018-07-23
• Label: 2018-08-09
• Letter: 2020-08-24
• Letter: 2020-08-27
• Label: 2020-08-27
• Letter: 2020-12-16
• Label: 2020-12-21
• Label: 2021-05-12
• Letter: 2021-05-12
• Label: 2021-09-13
• Letter: 2021-09-14

Application Sponsors

NDA 020758

SANOFI AVENTIS US

Marketing Status

• Discontinued: 001
• Prescription: 002
• Prescription: 003
• Discontinued: 004

Application Products

001	TABLET;ORAL	12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	AVALIDE	HYDROCHLOROTHIAZIDE; IRBESARTAN
002	TABLET;ORAL	12.5MG;150MG	1	AVALIDE	HYDROCHLOROTHIAZIDE; IRBESARTAN
003	TABLET;ORAL	12.5MG;300MG	1	AVALIDE	HYDROCHLOROTHIAZIDE; IRBESARTAN
004	TABLET;ORAL	25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	AVALIDE	HYDROCHLOROTHIAZIDE; IRBESARTAN

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	1997-09-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1998-01-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1998-08-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1998-04-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1998-09-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1998-07-15	STANDARD
LABELING; Labeling	SUPPL	7	AP	1998-07-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1999-01-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1999-03-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1999-03-16	STANDARD
LABELING; Labeling	SUPPL	11	AP	1999-04-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2000-08-23	STANDARD
LABELING; Labeling	SUPPL	13	AP	2001-09-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2000-04-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2000-08-01	STANDARD
LABELING; Labeling	SUPPL	16	AP	2000-05-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2000-05-10	STANDARD
LABELING; Labeling	SUPPL	18	AP	2000-09-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2001-02-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2001-03-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2001-06-07	STANDARD
S; Supplement	SUPPL	23	AP	2003-05-01	STANDARD
S; Supplement	SUPPL	28	AP	2003-10-10	STANDARD
S; Supplement	SUPPL	29	AP	2004-01-02	STANDARD
S; Supplement	SUPPL	30	AP	2004-07-21	STANDARD
S; Supplement	SUPPL	31	AP	2004-10-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	2005-03-15	STANDARD
LABELING; Labeling	SUPPL	35	AP	2005-11-21	STANDARD
LABELING; Labeling	SUPPL	36	AP	2006-04-21	STANDARD
EFFICACY; Efficacy	SUPPL	37	AP	2007-11-16	UNKNOWN
LABELING; Labeling	SUPPL	50	AP	2010-09-07	STANDARD
LABELING; Labeling	SUPPL	58	AP	2011-06-06	UNKNOWN
LABELING; Labeling	SUPPL	59	AP	2011-06-06	UNKNOWN
LABELING; Labeling	SUPPL	60	AP	2012-02-09	UNKNOWN
LABELING; Labeling	SUPPL	62	AP	2012-01-18	UNKNOWN
LABELING; Labeling	SUPPL	64	AP	2012-10-26	UNKNOWN
LABELING; Labeling	SUPPL	67	AP	2014-05-28	STANDARD
LABELING; Labeling	SUPPL	70	AP	2016-02-05	STANDARD
LABELING; Labeling	SUPPL	72	AP	2017-07-10	STANDARD
LABELING; Labeling	SUPPL	73	AP	2018-07-20	STANDARD
LABELING; Labeling	SUPPL	76	AP	2020-12-15	STANDARD
LABELING; Labeling	SUPPL	79	AP	2020-08-20	STANDARD
LABELING; Labeling	SUPPL	80	AP	2021-09-10	STANDARD
LABELING; Labeling	SUPPL	81	AP	2021-05-11	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	23	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	50	Null	7
SUPPL	58	Null	6
SUPPL	59	Null	6
SUPPL	60	Null	6
SUPPL	62	Null	15
SUPPL	64	Null	15
SUPPL	67	Null	7
SUPPL	70	Null	15
SUPPL	72	Null	15
SUPPL	73	Null	15
SUPPL	76	Null	7
SUPPL	79	Null	7
SUPPL	80	Null	7
SUPPL	81	Null	6

TE Codes

002	Prescription	AB
003	Prescription	AB

CDER Filings

SANOFI AVENTIS US

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20758
            [companyName] => SANOFI AVENTIS US
            [docInserts] => ["",""]
            [products] => [{"drugName":"AVALIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; IRBESARTAN","strength":"12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"AVALIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; IRBESARTAN","strength":"12.5MG;150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"AVALIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; IRBESARTAN","strength":"12.5MG;300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"AVALIDE","activeIngredients":"HYDROCHLOROTHIAZIDE; IRBESARTAN","strength":"25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"12\/15\/2020","submission":"SUPPL-76","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020758s076lbl.pdf\"}]","notes":""},{"actionDate":"08\/20\/2020","submission":"SUPPL-79","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020758s079lbl.pdf\"}]","notes":""},{"actionDate":"07\/20\/2018","submission":"SUPPL-73","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020758s073lbl.pdf\"}]","notes":""},{"actionDate":"07\/10\/2017","submission":"SUPPL-72","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020758s072lbl.pdf\"}]","notes":""},{"actionDate":"02\/05\/2016","submission":"SUPPL-70","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020758s070lbl.pdf\"}]","notes":""},{"actionDate":"05\/28\/2014","submission":"SUPPL-67","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020758s067lbl.pdf\"}]","notes":""},{"actionDate":"10\/26\/2012","submission":"SUPPL-64","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020758s064lbl.pdf\"}]","notes":""},{"actionDate":"02\/09\/2012","submission":"SUPPL-60","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020758s060lbl.pdf\"}]","notes":""},{"actionDate":"01\/18\/2012","submission":"SUPPL-62","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020758s062lbl.pdf\"}]","notes":""},{"actionDate":"06\/06\/2011","submission":"SUPPL-59","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020758s059lbl.pdf\"}]","notes":""},{"actionDate":"06\/06\/2011","submission":"SUPPL-58","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020758s058lbl.pdf\"}]","notes":""},{"actionDate":"09\/07\/2010","submission":"SUPPL-50","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020758s050lbl.pdf\"}]","notes":""},{"actionDate":"11\/16\/2007","submission":"SUPPL-37","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020758s037lbl.pdf\"}]","notes":""},{"actionDate":"04\/21\/2006","submission":"SUPPL-36","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020758s036lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"AVALIDE","submission":"HYDROCHLOROTHIAZIDE; IRBESARTAN","actionType":"12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"AVALIDE","submission":"HYDROCHLOROTHIAZIDE; IRBESARTAN","actionType":"12.5MG;150MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"AVALIDE","submission":"HYDROCHLOROTHIAZIDE; IRBESARTAN","actionType":"12.5MG;300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"AVALIDE","submission":"HYDROCHLOROTHIAZIDE; IRBESARTAN","actionType":"25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-12-15
        )

)