Documents
Application Sponsors
| NDA 021909 | SANOFI AVENTIS US | |
Marketing Status
| Discontinued | 002 |
| Discontinued | 003 |
Application Products
| 002 | TABLET, ORALLY DISINTEGRATING;ORAL | 30MG | 1 | CHILDREN'S ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE |
| 003 | TABLET, ORALLY DISINTEGRATING;ORAL | 30MG | 1 | CHILDREN'S ALLEGRA HIVES | FEXOFENADINE HYDROCHLORIDE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2007-07-26 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 3 | AP | 2011-01-24 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2012-08-23 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2013-04-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2014-01-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2013-12-09 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2016-06-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2016-08-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2016-08-05 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2020-12-03 | STANDARD |
Submissions Property Types
| SUPPL | 3 | Null | 7 |
| SUPPL | 6 | Null | 6 |
| SUPPL | 7 | Null | 6 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 15 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 15 | Null | 6 |
CDER Filings
SANOFI AVENTIS US
cder:Array
(
[0] => Array
(
[ApplNo] => 21909
[companyName] => SANOFI AVENTIS US
[docInserts] => ["",""]
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[labels] => [{"actionDate":"12\/03\/2020","submission":"SUPPL-15","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021909Orig1s015lbl.pdf\"}]","notes":""},{"actionDate":"06\/10\/2016","submission":"SUPPL-10","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021909Orig1s010lbl.pdf\"}]","notes":""},{"actionDate":"04\/28\/2013","submission":"SUPPL-7","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021909Orig1s007lbl.pdf\"}]","notes":""},{"actionDate":"01\/24\/2011","submission":"SUPPL-3","supplementCategories":"Efficacy-Rx To OTC Switch","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021909Orig1s003lbl.pdf\"}]","notes":""},{"actionDate":"07\/26\/2007","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021909lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"CHILDREN'S ALLEGRA ALLERGY","submission":"FEXOFENADINE HYDROCHLORIDE","actionType":"30MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"CHILDREN'S ALLEGRA HIVES","submission":"FEXOFENADINE HYDROCHLORIDE","actionType":"30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2020-12-03
)
)