NDA 021300

MERCK SHARP DOHME

FDA Drug Application

Application #021300

Documents

• Letter: 2004-09-03
• Letter: 2006-12-28
• Letter: 2014-04-24
• Label: 2014-04-25
• Letter: 2006-12-28
• Letter: 2006-12-28
• Letter: 2010-12-28
• Label: 2004-09-03
• Review: 2006-07-25
• Label: 2019-03-04
• Letter: 2019-03-05
• Letter: 2019-03-18
• Label: 2019-03-18

Application Sponsors

NDA 021300

MERCK SHARP DOHME

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

0.5MG/ML

1

CLARINEX

DESLORATADINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2004-09-01	STANDARD
LABELING; Labeling	SUPPL	3	AP	2006-12-14	STANDARD
LABELING; Labeling	SUPPL	4	AP	2006-12-14	STANDARD
LABELING; Labeling	SUPPL	5	AP	2006-12-14	STANDARD
LABELING; Labeling	SUPPL	11	AP	2010-12-22	STANDARD
LABELING; Labeling	SUPPL	14	AP	2014-04-23	STANDARD
LABELING; Labeling	SUPPL	17	AP	2019-03-01	STANDARD
LABELING; Labeling	SUPPL	19	AP	2019-03-15	STANDARD

Submissions Property Types

SUPPL	11	Null	31
SUPPL	14	Null	7
SUPPL	17	Null	15
SUPPL	19	Null	31

TE Codes

001

Prescription

AA

CDER Filings

MERCK SHARP DOHME

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21300
            [companyName] => MERCK SHARP DOHME
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLARINEX","activeIngredients":"DESLORATADINE","strength":"0.5MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/15\/2019","submission":"SUPPL-19","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-17","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":"04\/23\/2014","submission":"SUPPL-14","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":"09\/01\/2004","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21300lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CLARINEX","submission":"DESLORATADINE","actionType":"0.5MG\/ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-03-15
        )

)