NDA 019543

MERCK SHARP DOHME

FDA Drug Application

Application #019543

Documents

• Letter: 2002-07-17
• Letter: 2013-04-01
• Letter: 2002-07-17
• Letter: 2004-06-03
• Label: 2002-07-17
• Label: 2002-07-17
• Label: 2002-12-15
• Label: 2013-04-01
• Label: 2018-05-22
• Letter: 2018-05-24

Application Sponsors

NDA 019543

MERCK SHARP DOHME

Marketing Status

• Discontinued: 001

Application Products

001

OINTMENT;TOPICAL

0.1%

1

ELOCON

MOMETASONE FUROATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1987-04-30	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	1995-10-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1991-09-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1996-04-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1997-03-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1998-06-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1998-12-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1998-11-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2000-01-20	STANDARD
LABELING; Labeling	SUPPL	11	AP	2002-07-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2002-02-27	STANDARD
EFFICACY; Efficacy	SUPPL	13	AP	2002-07-17	STANDARD
LABELING; Labeling	SUPPL	14	AP	2002-12-15	STANDARD
LABELING; Labeling	SUPPL	24	AP	2013-03-28	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	2016-08-05	STANDARD
LABELING; Labeling	SUPPL	28	AP	2018-05-21	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	8
SUPPL	24	Null	15
SUPPL	28	Null	6

CDER Filings

MERCK SHARP DOHME

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19543
            [companyName] => MERCK SHARP DOHME
            [docInserts] => ["",""]
            [products] => [{"drugName":"ELOCON","activeIngredients":"MOMETASONE FUROATE","strength":"0.1%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"05\/21\/2018","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/019543s028lbl.pdf\"}]","notes":""},{"actionDate":"03\/28\/2013","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/019543s024lbl.pdf\"}]","notes":""},{"actionDate":"12\/15\/2002","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/19543slr014_Elocon_lbl.pdf\"}]","notes":""},{"actionDate":"07\/17\/2002","submission":"SUPPL-13","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/19543s11s13lbl.pdf\"}]","notes":""},{"actionDate":"07\/17\/2002","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/19543s11s13lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ELOCON","submission":"MOMETASONE FUROATE","actionType":"0.1%","submissionClassification":"OINTMENT;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-05-21
        )

)