NDA 021605

MERCK SHARP DOHME

FDA Drug Application

Application #021605

Documents

• Letter: 2005-03-10
• Letter: 2010-01-05
• Letter: 2014-03-10
• Label: 2014-03-10
• Label: 2005-03-10
• Label: 2010-01-12
• Review: 2007-05-09
• Letter: 2018-03-01
• Label: 2018-03-06
• Label: 2018-04-20
• Letter: 2018-04-23
• Letter: 2019-03-18
• Label: 2019-03-18

Application Sponsors

NDA 021605

MERCK SHARP DOHME

Marketing Status

• Prescription: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

5MG;240MG

1

CLARINEX D 24 HOUR

DESLORATADINE; PSEUDOEPHEDRINE SULFATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2005-03-03	STANDARD
LABELING; Labeling	SUPPL	6	AP	2009-12-30	STANDARD
LABELING; Labeling	SUPPL	12	AP	2014-03-07	STANDARD
LABELING; Labeling	SUPPL	13	AP	2018-04-19	STANDARD
LABELING; Labeling	SUPPL	15	AP	2018-02-28	STANDARD
LABELING; Labeling	SUPPL	17	AP	2019-03-15	STANDARD

Submissions Property Types

SUPPL	6	Null	6
SUPPL	12	Null	7
SUPPL	13	Null	7
SUPPL	15	Null	7
SUPPL	17	Null	7

TE Codes

001

Prescription

AB

CDER Filings

MERCK SHARP DOHME

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21605
            [companyName] => MERCK SHARP DOHME
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLARINEX D 24 HOUR","activeIngredients":"DESLORATADINE; PSEUDOEPHEDRINE SULFATE","strength":"5MG;240MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/15\/2019","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021605s017lbl.pdf\"}]","notes":""},{"actionDate":"04\/19\/2018","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021313s010,021605s013lbl.pdf\"}]","notes":""},{"actionDate":"02\/28\/2018","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021605s015lbl.pdf\"}]","notes":""},{"actionDate":"02\/28\/2018","submission":"SUPPL-15","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021605s015lbl.pdf\"}]","notes":""},{"actionDate":"03\/07\/2014","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021605s012lbl.pdf\"}]","notes":""},{"actionDate":"12\/30\/2009","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021605s006lbl.pdf\"}]","notes":""},{"actionDate":"03\/03\/2005","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021605lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CLARINEX D 24 HOUR","submission":"DESLORATADINE; PSEUDOEPHEDRINE SULFATE","actionType":"5MG;240MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-03-15
        )

)