Documents
Application Sponsors
| NDA 020757 | SANOFI AVENTIS US | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET;ORAL | 75MG | 1 | AVAPRO | IRBESARTAN |
| 002 | TABLET;ORAL | 150MG | 1 | AVAPRO | IRBESARTAN |
| 003 | TABLET;ORAL | 300MG | 1 | AVAPRO | IRBESARTAN |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | 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 | 1998-01-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1998-04-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1998-09-03 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 1998-12-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1999-03-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1999-03-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1999-11-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2000-08-23 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2001-09-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2000-04-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2000-08-01 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 14 | AP | 2001-05-26 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2000-05-09 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2000-05-10 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2000-09-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2001-02-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2001-03-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2001-06-07 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 21 | AP | 2002-09-17 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 2002-07-19 | STANDARD |
| S; Supplement | SUPPL | 23 | AP | 2003-03-21 | STANDARD |
| S; Supplement | SUPPL | 24 | AP | 2003-05-01 | STANDARD |
| S; Supplement | SUPPL | 25 | AP | 2003-03-21 | STANDARD |
| S; Supplement | SUPPL | 26 | AP | 2003-05-21 | STANDARD |
| S; Supplement | SUPPL | 27 | AP | 2003-10-09 | STANDARD |
| S; Supplement | SUPPL | 28 | AP | 2003-09-09 | STANDARD |
| S; Supplement | SUPPL | 30 | AP | 2004-01-02 | STANDARD |
| S; Supplement | SUPPL | 31 | AP | 2004-05-20 | STANDARD |
| S; Supplement | SUPPL | 32 | AP | 2004-07-21 | STANDARD |
| S; Supplement | SUPPL | 33 | AP | 2004-10-29 | STANDARD |
| LABELING; Labeling | SUPPL | 37 | AP | 2005-11-21 | STANDARD |
| LABELING; Labeling | SUPPL | 38 | AP | 2006-04-21 | STANDARD |
| LABELING; Labeling | SUPPL | 39 | AP | 2006-03-16 | STANDARD |
| LABELING; Labeling | SUPPL | 55 | AP | 2011-08-01 | UNKNOWN |
| LABELING; Labeling | SUPPL | 56 | AP | 2011-12-08 | UNKNOWN |
| LABELING; Labeling | SUPPL | 58 | AP | 2012-01-18 | UNKNOWN |
| LABELING; Labeling | SUPPL | 59 | AP | 2016-02-05 | UNKNOWN |
| LABELING; Labeling | SUPPL | 60 | AP | 2012-09-12 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 61 | AP | 2013-02-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 63 | AP | 2013-10-10 | STANDARD |
| LABELING; Labeling | SUPPL | 64 | AP | 2014-05-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 65 | AP | 2015-01-05 | STANDARD |
| LABELING; Labeling | SUPPL | 67 | AP | 2016-02-05 | STANDARD |
| LABELING; Labeling | SUPPL | 69 | AP | 2018-07-20 | STANDARD |
| LABELING; Labeling | SUPPL | 71 | AP | 2020-12-15 | STANDARD |
| LABELING; Labeling | SUPPL | 74 | AP | 2021-09-10 | STANDARD |
| LABELING; Labeling | SUPPL | 75 | 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 | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 55 | Null | 7 |
| SUPPL | 56 | Null | 7 |
| SUPPL | 58 | Null | 7 |
| SUPPL | 59 | Null | 15 |
| SUPPL | 60 | Null | 6 |
| SUPPL | 61 | Null | 0 |
| SUPPL | 63 | Null | 0 |
| SUPPL | 64 | Null | 6 |
| SUPPL | 65 | Null | 0 |
| SUPPL | 67 | Null | 15 |
| SUPPL | 69 | Null | 7 |
| SUPPL | 71 | Null | 7 |
| SUPPL | 74 | Null | 6 |
| SUPPL | 75 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
SANOFI AVENTIS US
cder:Array
(
[0] => Array
(
[ApplNo] => 20757
[companyName] => SANOFI AVENTIS US
[docInserts] => ["",""]
[products] => [{"drugName":"AVAPRO","activeIngredients":"IRBESARTAN","strength":"75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"AVAPRO","activeIngredients":"IRBESARTAN","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"AVAPRO","activeIngredients":"IRBESARTAN","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"12\/15\/2020","submission":"SUPPL-71","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020757s071lbl.pdf\"}]","notes":""},{"actionDate":"07\/20\/2018","submission":"SUPPL-69","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020757s069lbl.pdf\"}]","notes":""},{"actionDate":"02\/05\/2016","submission":"SUPPL-67","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020757s059s067lbl.pdf\"}]","notes":""},{"actionDate":"02\/05\/2016","submission":"SUPPL-59","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020757s059s067lbl.pdf\"}]","notes":""},{"actionDate":"05\/28\/2014","submission":"SUPPL-64","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020757s064lbl.pdf\"}]","notes":""},{"actionDate":"09\/12\/2012","submission":"SUPPL-60","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020757s060lbl.pdf\"}]","notes":""},{"actionDate":"01\/18\/2012","submission":"SUPPL-58","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020757s058lbl.pdf\"}]","notes":""},{"actionDate":"12\/08\/2011","submission":"SUPPL-56","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020757s056lbl.pdf\"}]","notes":""},{"actionDate":"08\/01\/2011","submission":"SUPPL-55","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020757s055lbl.pdf\"}]","notes":""},{"actionDate":"04\/21\/2006","submission":"SUPPL-38","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020757s038lbl.pdf\"}]","notes":""},{"actionDate":"03\/16\/2006","submission":"SUPPL-39","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020757s039lbl.pdf\"}]","notes":""},{"actionDate":"09\/17\/2002","submission":"SUPPL-21","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20757s21lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"AVAPRO","submission":"IRBESARTAN","actionType":"75MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"AVAPRO","submission":"IRBESARTAN","actionType":"150MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"AVAPRO","submission":"IRBESARTAN","actionType":"300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2020-12-15
)
)