Documents
Application Sponsors
NDA 020468 | SANOFI AVENTIS US | |
Marketing Status
Application Products
002 | SPRAY, METERED;NASAL | 0.055MG/SPRAY | 1 | NASACORT ALLERGY 24 HOUR | TRIAMCINOLONE ACETONIDE |
FDA Submissions
TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1996-05-20 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 2 | AP | 1997-09-26 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1996-10-15 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2000-08-17 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2002-03-12 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2002-05-06 | PRIORITY |
LABELING; Labeling | SUPPL | 11 | AP | 2003-12-17 | STANDARD |
LABELING; Labeling | SUPPL | 12 | AP | 2003-12-23 | STANDARD |
LABELING; Labeling | SUPPL | 13 | AP | 2004-03-08 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2013-12-07 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 24 | AP | 2008-09-19 | UNKNOWN |
EFFICACY; Efficacy | SUPPL | 33 | AP | 2013-07-02 | STANDARD |
EFFICACY; Efficacy | SUPPL | 34 | AP | 2013-07-02 | STANDARD |
EFFICACY; Efficacy | SUPPL | 35 | AP | 2013-10-11 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 2013-05-24 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 2013-12-07 | PRIORITY |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 2014-06-12 | PRIORITY |
LABELING; Labeling | SUPPL | 39 | AP | 2014-09-19 | STANDARD |
LABELING; Labeling | SUPPL | 40 | AP | 2015-06-18 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 41 | AP | 2016-03-22 | PRIORITY |
LABELING; Labeling | SUPPL | 42 | AP | 2016-09-22 | STANDARD |
LABELING; Labeling | SUPPL | 44 | AP | 2018-01-19 | STANDARD |
LABELING; Labeling | SUPPL | 46 | AP | 2018-10-17 | STANDARD |
Submissions Property Types
SUPPL | 1 | Null | 0 |
SUPPL | 3 | Null | 0 |
SUPPL | 5 | Null | 0 |
SUPPL | 7 | Null | 0 |
SUPPL | 8 | Null | 0 |
SUPPL | 20 | Null | 0 |
SUPPL | 24 | Null | 6 |
SUPPL | 33 | Null | 7 |
SUPPL | 34 | Null | 7 |
SUPPL | 35 | Null | 7 |
SUPPL | 36 | Null | 0 |
SUPPL | 37 | Null | 0 |
SUPPL | 38 | Null | 0 |
SUPPL | 39 | Null | 15 |
SUPPL | 40 | Null | 6 |
SUPPL | 41 | Null | 0 |
SUPPL | 42 | Null | 6 |
SUPPL | 44 | Null | 15 |
CDER Filings
SANOFI AVENTIS US
cder:Array
(
[0] => Array
(
[ApplNo] => 20468
[companyName] => SANOFI AVENTIS US
[docInserts] => ["",""]
[products] => [{"drugName":"NASACORT ALLERGY 24 HOUR","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"0.055MG\/SPRAY","dosageForm":"SPRAY, METERED;NASAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"10\/17\/2018","submission":"SUPPL-46","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020468Orig1s046lbl.pdf\"}]","notes":""},{"actionDate":"01\/19\/2018","submission":"SUPPL-44","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020468Orig1s044lbl.pdf\"}]","notes":""},{"actionDate":"09\/22\/2016","submission":"SUPPL-42","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020468Orig1s042lbl.pdf\"}]","notes":""},{"actionDate":"06\/18\/2015","submission":"SUPPL-40","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020468Orig1s040lbl.pdf\"}]","notes":""},{"actionDate":"09\/19\/2014","submission":"SUPPL-39","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020468Orig1s039lbl.pdf\"}]","notes":""},{"actionDate":"10\/11\/2013","submission":"SUPPL-35","supplementCategories":"Efficacy-Rx To OTC Switch","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020468Orig1s035lbl.pdf\"}]","notes":""},{"actionDate":"07\/02\/2013","submission":"SUPPL-34","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020468s033s034lbl.pdf\"}]","notes":""},{"actionDate":"07\/02\/2013","submission":"SUPPL-33","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020468s033s034lbl.pdf\"}]","notes":""},{"actionDate":"09\/19\/2008","submission":"SUPPL-24","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020468s024lbl.pdf\"}]","notes":""},{"actionDate":"03\/08\/2004","submission":"SUPPL-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20468slr013_nasacort_lbl.pdf\"}]","notes":""},{"actionDate":"12\/23\/2003","submission":"SUPPL-12","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20468slr012_nasacort_lbl.pdf\"}]","notes":""},{"actionDate":"12\/17\/2003","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20468slr011_nasacort_lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"NASACORT ALLERGY 24 HOUR","submission":"TRIAMCINOLONE ACETONIDE","actionType":"0.055MG\/SPRAY","submissionClassification":"SPRAY, METERED;NASAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2018-10-17
)
)