NDA 020010

MERCK SHARP DOHME

FDA Drug Application

Application #020010

Documents

• Letter: 2000-12-08
• Letter: 2002-12-17
• Letter: 2003-04-15
• Letter: 2008-02-21
• Letter: 2008-12-24
• Label: 2003-04-04
• Label: 2003-03-28
• Label: 2008-01-30
• Letter: 2006-04-25
• Letter: 2009-05-13
• Label: 2000-12-08
• Label: 2009-05-13
• Review: 2004-09-08

Application Sponsors

NDA 020010

MERCK SHARP DOHME

Marketing Status

• Prescription: 001

Application Products

001

LOTION;TOPICAL

EQ 0.05% BASE;1%

1

LOTRISONE

BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE

FDA Submissions

TYPE 3/4; Type 3 - New Dosage Form and Type 4 - New Combination	ORIG	1	AP	2000-12-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2002-04-04	STANDARD
LABELING; Labeling	SUPPL	3	AP	2002-12-17	STANDARD
LABELING; Labeling	SUPPL	5	AP	2003-03-27	STANDARD
LABELING; Labeling	SUPPL	11	AP	2006-04-24	STANDARD
LABELING; Labeling	SUPPL	15	AP	2008-01-25	STANDARD
LABELING; Labeling	SUPPL	20	AP	2008-12-18	STANDARD
LABELING; Labeling	SUPPL	21	AP	2009-05-11	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0

TE Codes

001

Prescription

AB

CDER Filings

MERCK SHARP DOHME

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20010
            [companyName] => MERCK SHARP DOHME
            [docInserts] => ["",""]
            [products] => [{"drugName":"LOTRISONE","activeIngredients":"BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE","strength":"EQ 0.05% BASE;1%","dosageForm":"LOTION;TOPICAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/11\/2009","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020010s021lbl.pdf\"}]","notes":""},{"actionDate":"01\/25\/2008","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020010s015lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2003","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20010slr005_lotrisone_lbl.pdf\"}]","notes":""},{"actionDate":"12\/17\/2002","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20010slr003_Lotrisone_lbl.pdf\"}]","notes":""},{"actionDate":"12\/08\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/20010lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"LOTRISONE","submission":"BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE","actionType":"EQ 0.05% BASE;1%","submissionClassification":"LOTION;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2009-05-11
        )

)