NDA 209090

SANOFI AVENTIS US

FDA Drug Application

Application #209090

Documents

• Label: 2017-01-31
• Letter: 2017-01-31
• Review: 2017-07-20
• Letter: 2020-11-12
• Label: 2021-04-09
• Label: 2022-07-14
• Letter: 2022-07-14
• Label: 2022-10-31
• Letter: 2022-10-31

Application Sponsors

NDA 209090

SANOFI AVENTIS US

Marketing Status

• Over-the-counter: 001

Application Products

001

SOLUTION;ORAL

2.5MG/5ML

1

XYZAL ALLERGY 24HR

LEVOCETIRIZINE DIHYDROCHLORIDE

FDA Submissions

TYPE 8; Type 8 - Partial Rx to OTC Switch	ORIG	1	AP	2017-01-31	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-11-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2022-07-13	N/A
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2022-10-28	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15

CDER Filings

SANOFI AVENTIS US

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209090
            [companyName] => SANOFI AVENTIS US
            [docInserts] => ["",""]
            [products] => [{"drugName":"XYZAL ALLERGY 24HR","activeIngredients":"LEVOCETIRIZINE DIHYDROCHLORIDE","strength":"2.5MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"01\/31\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209089Orig1s000,209090Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/31\/2017","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\\\/2017\\\/209089Orig1s000,209090Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209089Orig1s000,209090Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/209089Orig1s000_209090Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2017-01-31
        )

)