Documents
Application Sponsors
| NDA 020872 | SANOFI AVENTIS US | |
Marketing Status
| Discontinued | 005 |
| Discontinued | 006 |
| Over-the-counter | 007 |
| Discontinued | 008 |
| Discontinued | 009 |
| Over-the-counter | 010 |
Application Products
| 005 | TABLET;ORAL | 30MG | 1 | CHILDREN'S ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE |
| 006 | TABLET;ORAL | 30MG | 1 | CHILDREN'S ALLEGRA HIVES | FEXOFENADINE HYDROCHLORIDE |
| 007 | TABLET;ORAL | 60MG | 1 | ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE |
| 008 | TABLET;ORAL | 60MG | 1 | ALLEGRA HIVES | FEXOFENADINE HYDROCHLORIDE |
| 009 | TABLET;ORAL | 180MG | 1 | ALLEGRA HIVES | FEXOFENADINE HYDROCHLORIDE |
| 010 | TABLET;ORAL | 180MG | 1 | ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2000-02-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2000-03-21 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 3 | AP | 2003-05-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2001-05-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2001-01-05 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2001-07-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2002-02-20 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2002-12-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2002-10-10 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 11 | AP | 2003-05-12 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 15 | AP | 2005-10-13 | UNKNOWN |
| LABELING; Labeling | SUPPL | 18 | AP | 2008-06-25 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 23 | AP | 2011-01-24 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2012-02-23 | UNKNOWN |
| LABELING; Labeling | SUPPL | 29 | AP | 2012-08-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 2013-04-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 2014-04-16 | STANDARD |
| LABELING; Labeling | SUPPL | 32 | AP | 2014-09-12 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 2014-12-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 2015-09-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 2015-09-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 2016-03-23 | STANDARD |
| LABELING; Labeling | SUPPL | 38 | AP | 2016-05-10 | STANDARD |
| LABELING; Labeling | SUPPL | 46 | AP | 2021-10-13 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 6 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 7 | Null | 8 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 6 |
| SUPPL | 23 | Null | 6 |
| SUPPL | 25 | Null | 15 |
| SUPPL | 29 | Null | 6 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 32 | Null | 15 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 37 | Null | 0 |
| SUPPL | 38 | Null | 15 |
| SUPPL | 46 | Null | 15 |
CDER Filings
SANOFI AVENTIS US
cder:Array
(
[0] => Array
(
[ApplNo] => 20872
[companyName] => SANOFI AVENTIS US
[docInserts] => ["",""]
[products] => [{"drugName":"ALLEGRA ALLERGY","activeIngredients":"FEXOFENADINE HYDROCHLORIDE","strength":"60MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"No"},{"drugName":"ALLEGRA ALLERGY","activeIngredients":"FEXOFENADINE HYDROCHLORIDE","strength":"180MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"ALLEGRA HIVES","activeIngredients":"FEXOFENADINE HYDROCHLORIDE","strength":"60MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"ALLEGRA HIVES","activeIngredients":"FEXOFENADINE HYDROCHLORIDE","strength":"180MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"CHILDREN'S ALLEGRA ALLERGY","activeIngredients":"FEXOFENADINE HYDROCHLORIDE","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"CHILDREN'S ALLEGRA HIVES","activeIngredients":"FEXOFENADINE HYDROCHLORIDE","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"05\/10\/2016","submission":"SUPPL-38","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020872Orig1s038lbl.pdf\"}]","notes":""},{"actionDate":"09\/12\/2014","submission":"SUPPL-32","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020872Orig1s032lbl.pdf\"}]","notes":""},{"actionDate":"04\/16\/2014","submission":"SUPPL-31","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020872Orig1s031bl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"08\/23\/2012","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020872Orig1s029lbl.pdf\"}]","notes":""},{"actionDate":"02\/23\/2012","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020872Orig1s025lbl.pdf\"}]","notes":""},{"actionDate":"01\/24\/2011","submission":"SUPPL-23","supplementCategories":"Efficacy-Rx To OTC Switch","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020872Orig1s023lbl.pdf\"}]","notes":""},{"actionDate":"06\/25\/2008","submission":"SUPPL-18","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020872s018,021963s002lbl.pdf\"}]","notes":""},{"actionDate":"10\/13\/2005","submission":"SUPPL-15","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020872s015lbl.pdf\"}]","notes":""},{"actionDate":"05\/12\/2003","submission":"SUPPL-11","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":""},{"actionDate":"05\/12\/2003","submission":"SUPPL-3","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20872se8-003,20625se8-010_allegra_lbl.pdf\"}]","notes":""},{"actionDate":"02\/25\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/20872lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"ALLEGRA ALLERGY","submission":"FEXOFENADINE HYDROCHLORIDE","actionType":"60MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"},{"actionDate":"ALLEGRA ALLERGY","submission":"FEXOFENADINE HYDROCHLORIDE","actionType":"180MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"},{"actionDate":"ALLEGRA HIVES","submission":"FEXOFENADINE HYDROCHLORIDE","actionType":"60MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"ALLEGRA HIVES","submission":"FEXOFENADINE HYDROCHLORIDE","actionType":"180MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"CHILDREN'S ALLEGRA ALLERGY","submission":"FEXOFENADINE HYDROCHLORIDE","actionType":"30MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"CHILDREN'S ALLEGRA HIVES","submission":"FEXOFENADINE HYDROCHLORIDE","actionType":"30MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2016-05-10
)
)