NDA 018827

MERCK SHARP DOHME

FDA Drug Application

Application #018827

Documents

• Letter: 2003-04-15
• Letter: 2008-01-29
• Letter: 2009-05-13
• Letter: 2014-04-22
• Label: 2003-03-28
• Label: 2008-01-30
• Label: 2009-07-08
• Label: 2014-04-22
• Letter: 2003-07-31
• Label: 2003-04-15
• Label: 2005-07-29
• Label: 2018-05-22
• Letter: 2018-05-24
• Letter: 2019-06-17
• Label: 2019-06-17

Application Sponsors

NDA 018827

MERCK SHARP DOHME

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

EQ 0.05% BASE;1%

1

LOTRISONE

BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	1984-07-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1986-04-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1986-05-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1986-09-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1987-10-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1990-08-01	STANDARD
LABELING; Labeling	SUPPL	7	AP	2001-10-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1990-09-11	STANDARD
LABELING; Labeling	SUPPL	9	AP	2001-10-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1994-10-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1995-01-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1995-01-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1998-06-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1998-07-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1998-05-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1998-11-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1999-05-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2000-02-02	STANDARD
LABELING; Labeling	SUPPL	20	AP	2001-10-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2001-02-28	STANDARD
EFFICACY; Efficacy	SUPPL	22	AP	2001-10-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2002-01-10	STANDARD
LABELING; Labeling	SUPPL	25	AP	2003-03-27	STANDARD
LABELING; Labeling	SUPPL	38	AP	2008-01-25	STANDARD
LABELING; Labeling	SUPPL	42	AP	2009-05-11	STANDARD
LABELING; Labeling	SUPPL	46	AP	2014-04-21	STANDARD
LABELING; Labeling	SUPPL	49	AP	2018-05-21	STANDARD
LABELING; Labeling	SUPPL	50	AP	2019-06-14	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	8
SUPPL	24	Null	0
SUPPL	46	Null	7
SUPPL	49	Null	15
SUPPL	50	Null	6

TE Codes

001

Prescription

AB

CDER Filings

MERCK SHARP DOHME

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(
    [0] => Array
        (
            [ApplNo] => 18827
            [companyName] => MERCK SHARP DOHME
            [docInserts] => ["",""]
            [products] => [{"drugName":"LOTRISONE","activeIngredients":"BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE","strength":"EQ 0.05% BASE;1%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/14\/2019","submission":"SUPPL-50","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/018827s050lbl.pdf\"}]","notes":""},{"actionDate":"05\/21\/2018","submission":"SUPPL-49","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/018827s049lbl.pdf\"}]","notes":""},{"actionDate":"05\/21\/2018","submission":"SUPPL-49","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/018827s049lbl.pdf\"}]","notes":""},{"actionDate":"04\/21\/2014","submission":"SUPPL-46","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/018827s046lbl.pdf\"}]","notes":""},{"actionDate":"05\/11\/2009","submission":"SUPPL-42","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/018827s042lbl.pdf\"}]","notes":""},{"actionDate":"01\/25\/2008","submission":"SUPPL-38","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/018827s038lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2003","submission":"SUPPL-25","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/18827slr025_lotrisone_lbl.pdf\"}]","notes":""},{"actionDate":"10\/03\/2001","submission":"SUPPL-22","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/18827s22lbl.pdf\"}]","notes":""},{"actionDate":"10\/03\/2001","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/18827s7s9s20s22lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"LOTRISONE","submission":"BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE","actionType":"EQ 0.05% BASE;1%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-06-14
        )

)