NDA 021963

SANOFI AVENTIS US

FDA Drug Application

Application #021963

Documents

• Letter: 2008-06-30
• Letter: 2006-10-23
• Label: 2006-10-18
• Label: 2008-06-30
• Review: 2008-03-14
• Label: 2019-05-31
• Letter: 2019-06-04

Application Sponsors

NDA 021963

SANOFI AVENTIS US

Marketing Status

• Discontinued: 001

Application Products

001

SUSPENSION;ORAL

30MG/5ML

1

ALLEGRA

FEXOFENADINE HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2006-10-16	STANDARD
LABELING; Labeling	SUPPL	2	AP	2008-06-25	STANDARD
LABELING; Labeling	SUPPL	7	AP	2019-05-30	STANDARD

Submissions Property Types

SUPPL

7

Null

6

CDER Filings

SANOFI AVENTIS US

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21963
            [companyName] => SANOFI AVENTIS US
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALLEGRA","activeIngredients":"FEXOFENADINE HYDROCHLORIDE","strength":"30MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"05\/30\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021963s007lbl.pdf\"}]","notes":""},{"actionDate":"06\/25\/2008","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020872s018,021963s002lbl.pdf\"}]","notes":""},{"actionDate":"10\/16\/2006","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021963lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ALLEGRA","submission":"FEXOFENADINE HYDROCHLORIDE","actionType":"30MG\/5ML","submissionClassification":"SUSPENSION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-05-30
        )

)