NDA 014602

MERCK SHARP DOHME

FDA Drug Application

Application #014602

Documents

• Letter: 2008-06-30
• Letter: 2014-07-08
• Label: 2015-02-05
• Letter: 2006-07-21
• Letter: 2015-02-06
• Label: 2008-06-26
• Label: 2014-07-08
• Review: 2013-06-04
• Label: 2018-02-12
• Letter: 2018-02-14
• Label: 2018-04-11
• Letter: 2018-04-12
• Letter: 2022-09-08
• Label: 2022-09-10

Application Sponsors

NDA 014602

MERCK SHARP DOHME

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

3MG/ML;EQ 3MG BASE/ML

1

CELESTONE SOLUSPAN

BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1965-03-03	STANDARD
LABELING; Labeling	SUPPL	6	AP	1979-08-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1982-11-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1982-06-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1986-06-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1990-05-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1987-07-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1992-02-06	STANDARD
LABELING; Labeling	SUPPL	14	AP	1992-12-17
LABELING; Labeling	SUPPL	15	AP	1993-09-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1994-03-14	STANDARD
LABELING; Labeling	SUPPL	17	AP	1994-04-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1995-05-03	STANDARD
LABELING; Labeling	SUPPL	19	AP	2006-07-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1996-11-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1997-07-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1999-07-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1999-10-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2000-04-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2001-07-24	STANDARD
LABELING; Labeling	SUPPL	47	AP	2008-06-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	55	AP	2013-01-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	56	AP	2013-03-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	57	AP	2014-05-21	STANDARD
LABELING; Labeling	SUPPL	58	AP	2014-07-03	STANDARD
LABELING; Labeling	SUPPL	59	AP	2015-02-04	STANDARD
LABELING; Labeling	SUPPL	61	AP	2018-02-09	STANDARD
LABELING; Labeling	SUPPL	62	AP	2018-04-10	STANDARD
LABELING; Labeling	SUPPL	65	AP	2022-09-06	STANDARD

Submissions Property Types

SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	16	Null	0
SUPPL	18	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	55	Null	0
SUPPL	56	Null	0
SUPPL	57	Null	0
SUPPL	58	Null	15
SUPPL	59	Null	6
SUPPL	61	Null	31
SUPPL	62	Null	6
SUPPL	65	Null	31

TE Codes

001

Prescription

AB

CDER Filings

MERCK SHARP DOHME

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(
    [0] => Array
        (
            [ApplNo] => 14602
            [companyName] => MERCK SHARP DOHME
            [docInserts] => ["",""]
            [products] => [{"drugName":"CELESTONE SOLUSPAN","activeIngredients":"BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE","strength":"3MG\/ML;EQ 3MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/10\/2018","submission":"SUPPL-62","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/014602s062lbl.pdf\"}]","notes":""},{"actionDate":"02\/09\/2018","submission":"SUPPL-61","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/014602s061lbl.pdf\"}]","notes":""},{"actionDate":"02\/04\/2015","submission":"SUPPL-59","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/014602s059lbl.pdf\"}]","notes":""},{"actionDate":"07\/03\/2014","submission":"SUPPL-58","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/014602Orig1s058lbledt.pdf\"}]","notes":""},{"actionDate":"06\/24\/2008","submission":"SUPPL-47","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/014602s047lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CELESTONE SOLUSPAN","submission":"BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE","actionType":"3MG\/ML;EQ 3MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-04-10
        )

)