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001 | TABLET;ORAL | 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | AVALIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN |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004 | TABLET;ORAL | 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | AVALIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN |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