NDA 020762

MERCK SHARP DOHME

FDA Drug Application

Application #020762

Documents

• Letter: 2004-08-31
• Letter: 2003-03-10
• Letter: 2010-06-02
• Label: 2004-08-31
• Label: 2002-07-17
• Label: 2003-12-29
• Label: 2004-12-30
• Label: 2011-01-25
• Review: 2016-07-27
• Review: 2016-07-27
• Letter: 1998-11-18
• Letter: 2002-07-17
• Letter: 2003-12-23
• Letter: 2004-12-30
• Letter: 2011-01-25
• Label: 2010-05-28
• Review: 2010-03-03
• Review: 1998-11-18
• Review: 2008-04-02
• Review: 2007-07-09
• Review: 2013-02-27
• Review: 2016-07-27
• Pediatric Medical Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Letter: 2018-06-27
• Letter: 2018-06-27
• Label: 2018-06-28
• Label: 2018-06-28
• Medication Guide: 2018-07-06
• Letter: 2020-09-10
• Label: 2020-09-11
• Letter: 2022-06-29
• Label: 2022-06-29

Application Sponsors

NDA 020762

MERCK SHARP DOHME

Marketing Status

• Prescription: 001

Application Products

001

SPRAY, METERED;NASAL

0.05MG/SPRAY

1

NASONEX

MOMETASONE FUROATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1997-10-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1998-06-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1998-11-02	STANDARD
EFFICACY; Efficacy	SUPPL	4	AP	1999-12-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1999-04-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2004-08-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2000-10-04	STANDARD
LABELING; Labeling	SUPPL	9	AP	2000-12-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2001-02-22	STANDARD
EFFICACY; Efficacy	SUPPL	11	AP	2002-07-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2002-01-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2002-09-13	STANDARD
LABELING; Labeling	SUPPL	14	AP	2003-03-03	STANDARD
LABELING; Labeling	SUPPL	21	AP	2003-12-18	STANDARD
EFFICACY; Efficacy	SUPPL	23	AP	2004-12-15	UNKNOWN
EFFICACY; Efficacy	SUPPL	38	AP	2010-05-26	STANDARD
EFFICACY; Efficacy	SUPPL	44	AP	2011-01-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	48	AP	2012-11-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	49	AP	2014-04-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	50	AP	2014-10-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	51	AP	2015-03-03	STANDARD
LABELING; Labeling	SUPPL	52	AP	2018-06-22	STANDARD
LABELING; Labeling	SUPPL	53	AP	2018-06-22	STANDARD
LABELING; Labeling	SUPPL	55	AP	2020-09-09	STANDARD
LABELING; Labeling	SUPPL	56	AP	2022-06-28	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	8
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	38	Null	7
SUPPL	44	Null	6
SUPPL	48	Null	0
SUPPL	49	Null	0
SUPPL	50	Null	0
SUPPL	51	Null	0
SUPPL	52	Null	15
SUPPL	53	Null	31
SUPPL	55	Null	15
SUPPL	56	Null	15

TE Codes

001

Prescription

AB

CDER Filings

MERCK SHARP DOHME

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20762
            [companyName] => MERCK SHARP DOHME
            [docInserts] => ["",""]
            [products] => [{"drugName":"NASONEX","activeIngredients":"MOMETASONE FUROATE","strength":"0.05MG\/SPRAY","dosageForm":"SPRAY, METERED;NASAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/22\/2018","submission":"SUPPL-53","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020762s053lbl.pdf\"}]","notes":""},{"actionDate":"06\/22\/2018","submission":"SUPPL-52","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020762s052lbl.pdf\"}]","notes":""},{"actionDate":"01\/19\/2011","submission":"SUPPL-44","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020762s044lbl.pdf\"}]","notes":""},{"actionDate":"05\/26\/2010","submission":"SUPPL-38","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020762s038lbl.pdf\"}]","notes":""},{"actionDate":"12\/15\/2004","submission":"SUPPL-23","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20762s023lbl.pdf\"}]","notes":""},{"actionDate":"08\/25\/2004","submission":"SUPPL-7","supplementCategories":"Manufacturing (CMC)-Formulation","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20762s007lbl.pdf\"}]","notes":""},{"actionDate":"12\/18\/2003","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20762slr021_nasonex_lbl.pdf\"}]","notes":""},{"actionDate":"07\/17\/2002","submission":"SUPPL-11","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20762s11lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"NASONEX","submission":"MOMETASONE FUROATE","actionType":"0.05MG\/SPRAY","submissionClassification":"SPRAY, METERED;NASAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-06-22
        )

)