NDA 019796

MERCK SHARP DOHME

FDA Drug Application

Application #019796

Documents

• Letter: 2002-07-17
• Letter: 2005-09-15
• Letter: 2013-04-01
• Label: 2002-07-17
• Label: 2013-04-01
• Letter: 2002-07-17
• Label: 2002-07-17
• Label: 2005-09-15
• Label: 2018-05-22
• Letter: 2018-05-24

Application Sponsors

NDA 019796

MERCK SHARP DOHME

Marketing Status

• Prescription: 001

Application Products

001

LOTION;TOPICAL

0.1%

1

ELOCON

MOMETASONE FUROATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1989-03-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1991-09-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1992-03-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1996-01-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1996-04-16	STANDARD
LABELING; Labeling	SUPPL	8	AP	2002-07-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1998-06-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1998-11-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1998-12-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1999-05-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2000-09-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2001-07-13	STANDARD
EFFICACY; Efficacy	SUPPL	15	AP	2002-07-17	STANDARD
LABELING; Labeling	SUPPL	20	AP	2005-09-09	STANDARD
LABELING; Labeling	SUPPL	26	AP	2013-03-28	UNKNOWN
LABELING; Labeling	SUPPL	29	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	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	8
SUPPL	26	Null	15
SUPPL	29	Null	7

TE Codes

001

Prescription

AB

CDER Filings

MERCK SHARP DOHME

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19796
            [companyName] => MERCK SHARP DOHME
            [docInserts] => ["",""]
            [products] => [{"drugName":"ELOCON","activeIngredients":"MOMETASONE FUROATE","strength":"0.1%","dosageForm":"LOTION;TOPICAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/21\/2018","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/019796s029lbl.pdf\"}]","notes":""},{"actionDate":"03\/28\/2013","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/019796s026lbl.pdf\"}]","notes":""},{"actionDate":"09\/09\/2005","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/019796s020lbl.pdf\"}]","notes":""},{"actionDate":"07\/17\/2002","submission":"SUPPL-15","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/19796s8s15lbl.pdf\"}]","notes":""},{"actionDate":"07\/17\/2002","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/19796s8s15lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ELOCON","submission":"MOMETASONE FUROATE","actionType":"0.1%","submissionClassification":"LOTION;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-05-21
        )

)