NDA 021165

MERCK SHARP DOHME

FDA Drug Application

Application #021165

Documents

• Letter: 2004-02-03
• Letter: 2006-12-28
• Letter: 2006-12-28
• Letter: 2010-12-28
• Letter: 2014-04-24
• Label: 2001-12-21
• Label: 2012-05-03
• Letter: 2001-12-21
• Letter: 2002-02-08
• Letter: 2006-12-28
• Label: 2004-06-01
• Label: 2014-04-25
• Review: 2001-12-21
• Review: 2003-07-08
• Label: 2019-03-04
• Letter: 2019-03-05
• Letter: 2019-03-18
• Label: 2019-04-04

Application Sponsors

NDA 021165

MERCK SHARP DOHME

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

5MG

1

CLARINEX

DESLORATADINE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2001-12-21	STANDARD
LABELING; Labeling	SUPPL	6	AP	2004-01-29	STANDARD
LABELING; Labeling	SUPPL	7	AP	2006-12-14	STANDARD
LABELING; Labeling	SUPPL	8	AP	2006-12-14	STANDARD
LABELING; Labeling	SUPPL	9	AP	2006-12-14	STANDARD
LABELING; Labeling	SUPPL	14	AP	2010-12-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2013-07-23	STANDARD
LABELING; Labeling	SUPPL	17	AP	2014-04-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2016-06-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2016-06-16	STANDARD
LABELING; Labeling	SUPPL	20	AP	2019-03-01	STANDARD
LABELING; Labeling	SUPPL	22	AP	2019-03-15	STANDARD

Submissions Property Types

SUPPL	14	Null	7
SUPPL	16	Null	0
SUPPL	17	Null	15
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	15
SUPPL	22	Null	33

TE Codes

001

Prescription

AB

CDER Filings

MERCK SHARP DOHME

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21165
            [companyName] => MERCK SHARP DOHME
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLARINEX","activeIngredients":"DESLORATADINE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/15\/2019","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021165s022,021300s019,021312s020,021563s008lbl.pdf\"}]","notes":""},{"actionDate":"03\/01\/2019","submission":"SUPPL-20","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021165s020,021300s017,021312s018,021563s006lbl.pdf\"}]","notes":""},{"actionDate":"03\/01\/2019","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021165s020,021300s017,021312s018,021563s006lbl.pdf\"}]","notes":""},{"actionDate":"04\/23\/2014","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021165s017,021300s014,021312s015,021563s003lbl.pdf\"}]","notes":""},{"actionDate":"12\/22\/2010","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021165s014lbl.pdf\"}]","notes":""},{"actionDate":"12\/22\/2010","submission":"SUPPL-14","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021165s014lbl.pdf\"}]","notes":""},{"actionDate":"02\/08\/2002","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2002\\\/21165s001_Clarinex_Prntlbl.pdf\"}]","notes":""},{"actionDate":"12\/21\/2001","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/21165lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CLARINEX","submission":"DESLORATADINE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-03-15
        )

)