Documents
Application Sponsors
NDA 020786 | SANOFI AVENTIS US | |
Marketing Status
Application Products
002 | TABLET, EXTENDED RELEASE;ORAL | 60MG;120MG | 1 | ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION | FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
FDA Submissions
TYPE 4; Type 4 - New Combination | ORIG | 1 | AP | 1997-12-24 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1999-12-21 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 1998-12-22 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2000-01-21 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1999-12-01 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2000-01-06 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2000-09-26 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2001-01-19 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2002-10-29 | STANDARD |
LABELING; Labeling | SUPPL | 12 | AP | 2002-11-01 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2001-10-31 | STANDARD |
EFFICACY; Efficacy | SUPPL | 14 | AP | 2003-05-12 | PRIORITY |
LABELING; Labeling | SUPPL | 17 | AP | 2004-12-06 | STANDARD |
LABELING; Labeling | SUPPL | 26 | AP | 2010-04-14 | UNKNOWN |
EFFICACY; Efficacy | SUPPL | 27 | AP | 2011-01-24 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 2012-02-03 | STANDARD |
LABELING; Labeling | SUPPL | 29 | AP | 2012-08-23 | STANDARD |
LABELING; Labeling | SUPPL | 31 | AP | 2012-12-05 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 2014-05-14 | STANDARD |
EFFICACY; Efficacy | SUPPL | 33 | AP | 2015-06-08 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 2015-07-09 | STANDARD |
LABELING; Labeling | SUPPL | 35 | AP | 2016-06-02 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 2016-10-31 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 2016-10-31 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 31 |
SUPPL | 2 | Null | 0 |
SUPPL | 4 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 6 | Null | 0 |
SUPPL | 8 | Null | 0 |
SUPPL | 9 | Null | 0 |
SUPPL | 11 | Null | 0 |
SUPPL | 13 | Null | 0 |
SUPPL | 14 | Null | 6 |
SUPPL | 26 | Null | 6 |
SUPPL | 27 | Null | 6 |
SUPPL | 28 | Null | 0 |
SUPPL | 29 | Null | 15 |
SUPPL | 31 | Null | 7 |
SUPPL | 32 | Null | 0 |
SUPPL | 33 | Null | 15 |
SUPPL | 34 | Null | 0 |
SUPPL | 35 | Null | 15 |
CDER Filings
SANOFI AVENTIS US
cder:Array
(
[0] => Array
(
[ApplNo] => 20786
[companyName] => SANOFI AVENTIS US
[docInserts] => ["",""]
[products] => [{"drugName":"ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION","activeIngredients":"FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE","strength":"60MG;120MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"06\/02\/2016","submission":"SUPPL-35","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-33","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"12\/05\/2012","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020786s031lbl.pdf\"}]","notes":""},{"actionDate":"08\/23\/2012","submission":"SUPPL-29","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020786s029lbl.pdf\"}]","notes":""},{"actionDate":"01\/24\/2011","submission":"SUPPL-27","supplementCategories":"Efficacy-Rx To OTC Switch","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020786Orig1s027lbl.pdf\"}]","notes":""},{"actionDate":"04\/14\/2010","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020786s026lbl.pdf\"}]","notes":""},{"actionDate":"05\/12\/2003","submission":"SUPPL-14","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20786se8-014,20872se8-011,20625se8-012_allegra_lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION","submission":"FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE","actionType":"60MG;120MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2016-06-02
)
)