NDA 018741

MERCK SHARP DOHME

FDA Drug Application

Application #018741

Documents

• Letter: 2006-09-18
• Label: 2006-02-22
• Letter: 2005-10-14
• Letter: 2006-02-22
• Letter: 2014-08-14
• Label: 2005-10-14
• Label: 2006-08-29
• Label: 2014-08-15
• Label: 2018-04-01
• Letter: 2018-04-01
• Letter: 2019-05-02
• Label: 2019-05-02

Application Sponsors

NDA 018741

MERCK SHARP DOHME

Marketing Status

• Prescription: 001

Application Products

001

OINTMENT, AUGMENTED;TOPICAL

EQ 0.05% BASE

1

DIPROLENE

BETAMETHASONE DIPROPIONATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1983-07-27	STANDARD
LABELING; Labeling	SUPPL	2	AP	1983-12-15
LABELING; Labeling	SUPPL	3	AP	1984-11-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1985-02-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1986-04-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1986-05-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1986-09-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1987-10-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1988-11-30	STANDARD
LABELING; Labeling	SUPPL	13	AP	1989-05-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1990-08-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1991-11-08	STANDARD
LABELING; Labeling	SUPPL	16	AP	2005-10-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1995-11-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1998-06-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1998-07-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1998-06-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1998-11-10	STANDARD
EFFICACY; Efficacy	SUPPL	28	AP	2006-08-28	STANDARD
LABELING; Labeling	SUPPL	36	AP	2014-08-13	STANDARD
LABELING; Labeling	SUPPL	38	AP	2018-03-28	STANDARD
LABELING; Labeling	SUPPL	40	AP	2019-05-01	STANDARD

Submissions Property Types

SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	36	Null	7
SUPPL	38	Null	7
SUPPL	40	Null	7

TE Codes

001

Prescription

AB

CDER Filings

MERCK SHARP DOHME

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18741
            [companyName] => MERCK SHARP DOHME
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIPROLENE","activeIngredients":"BETAMETHASONE DIPROPIONATE","strength":"EQ 0.05% BASE","dosageForm":"OINTMENT, AUGMENTED;TOPICAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/01\/2019","submission":"SUPPL-40","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/018741s040lbl.pdf\"}]","notes":""},{"actionDate":"03\/28\/2018","submission":"SUPPL-38","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/018741s038lbl.pdf\"}]","notes":""},{"actionDate":"08\/13\/2014","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/018741s036lbl.pdf\"}]","notes":""},{"actionDate":"08\/28\/2006","submission":"SUPPL-28","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/018741s028lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2005","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/018741s016lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2005","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/018741s016lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"DIPROLENE","submission":"BETAMETHASONE DIPROPIONATE","actionType":"EQ 0.05% BASE","submissionClassification":"OINTMENT, AUGMENTED;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-05-01
        )

)