NDA 019716

MERCK SHARP DOHME

FDA Drug Application

Application #019716

Documents

• Letter: 2005-10-14
• Letter: 2006-04-25
• Label: 2006-08-28
• Label: 2014-08-15
• Letter: 2006-09-18
• Letter: 2014-08-14
• Label: 2005-10-14
• Label: 2018-04-01
• Letter: 2018-04-01
• Letter: 2019-05-02
• Label: 2019-05-02

Application Sponsors

NDA 019716

MERCK SHARP DOHME

Marketing Status

• Discontinued: 001

Application Products

001

LOTION, AUGMENTED;TOPICAL

EQ 0.05% BASE

1

DIPROLENE

BETAMETHASONE DIPROPIONATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1988-08-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1989-04-06	STANDARD
LABELING; Labeling	SUPPL	3	AP	1989-05-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1990-08-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1992-07-01	STANDARD
LABELING; Labeling	SUPPL	6	AP	2005-10-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1996-01-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1998-06-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1998-07-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1999-05-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2000-09-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2001-05-11	STANDARD
LABELING; Labeling	SUPPL	21	AP	2006-04-24	STANDARD
EFFICACY; Efficacy	SUPPL	22	AP	2006-08-28	STANDARD
LABELING; Labeling	SUPPL	30	AP	2014-08-13	STANDARD
LABELING; Labeling	SUPPL	32	AP	2018-03-28	STANDARD
LABELING; Labeling	SUPPL	33	AP	2019-05-01	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	30	Null	7
SUPPL	32	Null	7
SUPPL	33	Null	7

CDER Filings

MERCK SHARP DOHME

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19716
            [companyName] => MERCK SHARP DOHME
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIPROLENE","activeIngredients":"BETAMETHASONE DIPROPIONATE","strength":"EQ 0.05% BASE","dosageForm":"LOTION, AUGMENTED;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"05\/01\/2019","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/019716s033lbl.pdf\"}]","notes":""},{"actionDate":"03\/28\/2018","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/019716s032lbl.pdf\"}]","notes":""},{"actionDate":"08\/13\/2014","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/019716s030lbl.pdf\"}]","notes":""},{"actionDate":"08\/28\/2006","submission":"SUPPL-22","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/019716s022lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2005","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/019716s006lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"DIPROLENE","submission":"BETAMETHASONE DIPROPIONATE","actionType":"EQ 0.05% BASE","submissionClassification":"LOTION, AUGMENTED;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-05-01
        )

)