Documents
Application Sponsors
| NDA 021704 | SANOFI AVENTIS US | |
Marketing Status
Application Products
| 002 | TABLET, EXTENDED RELEASE;ORAL | 180MG;240MG | 1 | ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION | FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2004-10-19 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2010-04-14 | UNKNOWN |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2011-01-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2012-02-03 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2012-08-23 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2012-12-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2014-01-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2013-10-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2014-01-30 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 17 | AP | 2015-06-08 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2016-06-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2016-10-31 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 31 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 8 | Null | 31 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 15 |
| SUPPL | 13 | Null | 7 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 15 |
| SUPPL | 18 | Null | 6 |
CDER Filings
SANOFI AVENTIS US
cder:Array
(
[0] => Array
(
[ApplNo] => 21704
[companyName] => SANOFI AVENTIS US
[docInserts] => ["",""]
[products] => [{"drugName":"ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION","activeIngredients":"FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE","strength":"180MG;240MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"06\/02\/2016","submission":"SUPPL-18","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020786Origs035,021704Orig1s018lbl.pdf\"}]","notes":""},{"actionDate":"06\/08\/2015","submission":"SUPPL-17","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"12\/05\/2012","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021704s013lbl.pdf\"}]","notes":""},{"actionDate":"01\/24\/2011","submission":"SUPPL-8","supplementCategories":"Efficacy-Rx To OTC Switch","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021704Orig1s008lbl.pdf\"}]","notes":""},{"actionDate":"04\/14\/2010","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021704s007lbl.pdf\"}]","notes":""},{"actionDate":"10\/19\/2004","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21704lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION","submission":"FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE","actionType":"180MG;240MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2016-06-02
)
)