SANOFI AVENTIS US FDA Approval NDA 020468

NDA 020468

SANOFI AVENTIS US

FDA Drug Application

Application #020468

Documents

Letter2004-01-09
Letter2004-03-10
Letter2008-09-23
Letter2013-07-03
Letter2015-06-22
Label2003-12-29
Label2004-04-05
Label2008-09-25
Label2013-07-03
Label2013-10-15
Label2015-06-22
Letter2003-12-22
Letter2013-07-03
Letter2013-10-11
Letter2014-09-23
Label2004-01-15
Label2013-07-03
Label2014-09-23
Review2008-08-11
Letter2016-10-12
Label2016-10-11
Label2018-01-22
Letter2018-01-26
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01
Letter2018-10-23
Label2018-10-26

Application Sponsors

NDA 020468SANOFI AVENTIS US

Marketing Status

Over-the-counter002

Application Products

002SPRAY, METERED;NASAL0.055MG/SPRAY1NASACORT ALLERGY 24 HOURTRIAMCINOLONE ACETONIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1996-05-20PRIORITY
EFFICACY; EfficacySUPPL2AP1997-09-26STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1996-10-15PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL5AP2000-08-17PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL7AP2002-03-12PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2002-05-06PRIORITY
LABELING; LabelingSUPPL11AP2003-12-17STANDARD
LABELING; LabelingSUPPL12AP2003-12-23STANDARD
LABELING; LabelingSUPPL13AP2004-03-08STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL20AP2013-12-07PRIORITY
EFFICACY; EfficacySUPPL24AP2008-09-19UNKNOWN
EFFICACY; EfficacySUPPL33AP2013-07-02STANDARD
EFFICACY; EfficacySUPPL34AP2013-07-02STANDARD
EFFICACY; EfficacySUPPL35AP2013-10-11STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL36AP2013-05-24PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL37AP2013-12-07PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL38AP2014-06-12PRIORITY
LABELING; LabelingSUPPL39AP2014-09-19STANDARD
LABELING; LabelingSUPPL40AP2015-06-18STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL41AP2016-03-22PRIORITY
LABELING; LabelingSUPPL42AP2016-09-22STANDARD
LABELING; LabelingSUPPL44AP2018-01-19STANDARD
LABELING; LabelingSUPPL46AP2018-10-17STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL3Null0
SUPPL5Null0
SUPPL7Null0
SUPPL8Null0
SUPPL20Null0
SUPPL24Null6
SUPPL33Null7
SUPPL34Null7
SUPPL35Null7
SUPPL36Null0
SUPPL37Null0
SUPPL38Null0
SUPPL39Null15
SUPPL40Null6
SUPPL41Null0
SUPPL42Null6
SUPPL44Null15

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
        )

)
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