Documents
Application Sponsors
| NDA 201373 | SANOFI AVENTIS US | |
Marketing Status
| Over-the-counter | 001 |
| Discontinued | 002 |
Application Products
| 001 | SUSPENSION;ORAL | 30MG/5ML | 1 | CHILDREN'S ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE |
| 002 | SUSPENSION;ORAL | 30MG/5ML | 1 | CHILDREN'S ALLEGRA HIVES | FEXOFENADINE HYDROCHLORIDE |
FDA Submissions
| TYPE 8; Type 8 - Partial Rx to OTC Switch | ORIG | 1 | AP | 2011-01-24 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2012-02-23 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2012-08-23 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2013-04-28 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2016-06-15 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2020-11-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2021-03-17 | N/A |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2022-12-20 | N/A |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2022-12-27 | N/A |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 4 | Null | 6 |
| SUPPL | 5 | Null | 6 |
| SUPPL | 6 | Null | 6 |
| SUPPL | 10 | Null | 7 |
CDER Filings
SANOFI AVENTIS US
cder:Array
(
[0] => Array
(
[ApplNo] => 201373
[companyName] => SANOFI AVENTIS US
[docInserts] => ["",""]
[products] => [{"drugName":"CHILDREN'S ALLEGRA ALLERGY","activeIngredients":"FEXOFENADINE HYDROCHLORIDE","strength":"30MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"CHILDREN'S ALLEGRA HIVES","activeIngredients":"FEXOFENADINE HYDROCHLORIDE","strength":"30MG\/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"11\/02\/2020","submission":"SUPPL-10","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/201373Orig1s010lbl.pdf\"}]","notes":""},{"actionDate":"06\/15\/2016","submission":"SUPPL-6","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/201373Orig1s006lbl.pdf\"}]","notes":""},{"actionDate":"04\/28\/2013","submission":"SUPPL-5","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/201373Orig1s005lbl.pdf\"}]","notes":""},{"actionDate":"01\/24\/2011","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/201373Orig1s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"01\/24\/2011","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 8 - Partial Rx to OTC Switch","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/201373Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/201373s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2011\\\/201373_allegra_toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2011\\\/201373Orig1s000SumR.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"11\/02\/2020","submission":"SUPPL-10","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/201373Orig1s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/201373Orig1s010ltr.pdf\"}]","notes":">"},{"actionDate":"06\/15\/2016","submission":"SUPPL-6","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/201373Orig1s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/201373Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"04\/28\/2013","submission":"SUPPL-5","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/201373Orig1s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/201373Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"08\/23\/2012","submission":"SUPPL-4","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/201373Orig1s004ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"02\/23\/2012","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/201373s002ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-11-02
)
)