Documents
Application Sponsors
| NDA 022157 | SANOFI AVENTIS US | |
Marketing Status
Application Products
| 001 | SOLUTION;ORAL | 2.5MG/5ML | 1 | XYZAL | LEVOCETIRIZINE DIHYDROCHLORIDE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2008-01-28 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 3 | AP | 2009-08-21 | PRIORITY |
| LABELING; Labeling | SUPPL | 7 | AP | 2011-03-07 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2012-09-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2015-01-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2014-02-14 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2013-11-07 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2016-06-23 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2017-02-09 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2016-11-08 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2017-07-10 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2017-10-16 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2018-04-02 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2019-01-11 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2019-04-02 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 31 |
| SUPPL | 3 | Null | 31 |
| SUPPL | 7 | Null | 6 |
| SUPPL | 8 | Null | 6 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 15 |
| SUPPL | 13 | Null | 6 |
| SUPPL | 14 | Null | 7 |
| SUPPL | 15 | Null | 7 |
| SUPPL | 16 | Null | 15 |
| SUPPL | 17 | Null | 6 |
| SUPPL | 18 | Null | 6 |
| SUPPL | 19 | Null | 7 |
| SUPPL | 20 | Null | 7 |
TE Codes
CDER Filings
SANOFI AVENTIS US
cder:Array
(
[0] => Array
(
[ApplNo] => 22157
[companyName] => SANOFI AVENTIS US
[docInserts] => ["",""]
[products] => [{"drugName":"XYZAL","activeIngredients":"LEVOCETIRIZINE DIHYDROCHLORIDE","strength":"2.5MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"04\/02\/2019","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022064s038,022157s020lbl.pdf\"}]","notes":""},{"actionDate":"01\/11\/2019","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022064s037,022157s019lbl.pdf\"}]","notes":""},{"actionDate":"04\/02\/2018","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022157s018lbl.pdf\"}]","notes":""},{"actionDate":"10\/16\/2017","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022157s017lbl.pdf\"}]","notes":""},{"actionDate":"07\/10\/2017","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022064s033,022157s016lbl.pdf\"}]","notes":""},{"actionDate":"02\/09\/2017","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022064s031,022157s014lbl.pdf\"}]","notes":""},{"actionDate":"11\/08\/2016","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022064s032_022157s015lbl.pdf\"}]","notes":""},{"actionDate":"06\/23\/2016","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022064s030,022157s013lbl.pdf\"}]","notes":""},{"actionDate":"11\/07\/2013","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022064s028_022157s012lbl.pdf\"}]","notes":""},{"actionDate":"09\/06\/2012","submission":"SUPPL-8","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022064s024,022157s008lbl.pdf\"}]","notes":""},{"actionDate":"03\/07\/2011","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022064s020,022157s007lbl.pdf\"}]","notes":""},{"actionDate":"08\/21\/2009","submission":"SUPPL-3","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022064s017,022157s003lbl.pdf\"}]","notes":""},{"actionDate":"06\/25\/2008","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/022157s001lbl.pdf\"}]","notes":""},{"actionDate":"01\/28\/2008","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/022157lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"XYZAL","submission":"LEVOCETIRIZINE DIHYDROCHLORIDE","actionType":"2.5MG\/5ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-04-02
)
)