NDA 019555

MERCK SHARP DOHME

FDA Drug Application

Application #019555

Documents

• Label: 2014-08-15
• Letter: 2001-10-03
• Letter: 2001-10-03
• Letter: 2006-09-18
• Letter: 2014-08-14
• Review: 2001-10-03
• Review: 2001-10-03
• Label: 2001-10-03
• Label: 2001-10-03
• Label: 2006-08-28
• Label: 2018-04-01
• Letter: 2018-04-01
• Letter: 2019-05-02
• Label: 2019-05-02

Application Sponsors

NDA 019555

MERCK SHARP DOHME

Marketing Status

• Discontinued: 001

Application Products

001

CREAM, AUGMENTED;TOPICAL

EQ 0.05% BASE

1

DIPROLENE AF

BETAMETHASONE DIPROPIONATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1987-04-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1987-10-29	STANDARD
LABELING; Labeling	SUPPL	4	AP	1988-11-08
LABELING; Labeling	SUPPL	5	AP	1989-05-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1990-08-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1990-06-29	STANDARD
LABELING; Labeling	SUPPL	8	AP	2001-10-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1995-11-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1998-06-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1998-07-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1998-12-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1998-11-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1999-05-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2000-08-14	STANDARD
EFFICACY; Efficacy	SUPPL	16	AP	2001-10-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2001-04-04	STANDARD
EFFICACY; Efficacy	SUPPL	26	AP	2006-08-28	STANDARD
LABELING; Labeling	SUPPL	33	AP	2014-08-13	STANDARD
LABELING; Labeling	SUPPL	34	AP	2018-03-28	STANDARD
LABELING; Labeling	SUPPL	35	AP	2019-05-01	STANDARD

Submissions Property Types

SUPPL	2	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	0
SUPPL	16	Null	6
SUPPL	17	Null	0
SUPPL	33	Null	7
SUPPL	34	Null	7
SUPPL	35	Null	7

CDER Filings

MERCK SHARP DOHME

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19555
            [companyName] => MERCK SHARP DOHME
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIPROLENE AF","activeIngredients":"BETAMETHASONE DIPROPIONATE","strength":"EQ 0.05% BASE","dosageForm":"CREAM, AUGMENTED;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"05\/01\/2019","submission":"SUPPL-35","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/019555s035lbl.pdf\"}]","notes":""},{"actionDate":"03\/28\/2018","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/019555s034lbl.pdf\"}]","notes":""},{"actionDate":"08\/13\/2014","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/019555s033lbl.pdf\"}]","notes":""},{"actionDate":"08\/28\/2006","submission":"SUPPL-26","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/019555s026lbl.pdf\"}]","notes":""},{"actionDate":"10\/03\/2001","submission":"SUPPL-16","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/19555s8lbl.pdf\"}]","notes":""},{"actionDate":"10\/03\/2001","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/19555s8lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"DIPROLENE AF","submission":"BETAMETHASONE DIPROPIONATE","actionType":"EQ 0.05% BASE","submissionClassification":"CREAM, AUGMENTED;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-05-01
        )

)