NDA 021159

BAUSCH

FDA Drug Application

Application #021159

Documents

• Letter: 2004-02-27
• Letter: 2012-12-11
• Letter: 2013-05-10
• Letter: 2003-03-10
• Letter: 2006-06-14
• Label: 2003-02-28
• Label: 2006-06-14
• Label: 2012-12-07
• Label: 2013-05-14
• Review: 2003-07-08

Application Sponsors

NDA 021159

BAUSCH

Marketing Status

• Prescription: 001

Application Products

001

SHAMPOO;TOPICAL

1%

1

LOPROX

CICLOPIROX

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2003-02-28	STANDARD
LABELING; Labeling	SUPPL	9	AP	2006-06-12	STANDARD
LABELING; Labeling	SUPPL	19	AP	2012-12-06	UNKNOWN
LABELING; Labeling	SUPPL	20	AP	2013-05-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2015-02-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2016-04-07	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	19	Null	7
SUPPL	20	Null	7
SUPPL	21	Null	0
SUPPL	22	Null	0

TE Codes

001

Prescription

AT

CDER Filings

BAUSCH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21159
            [companyName] => BAUSCH
            [docInserts] => ["",""]
            [products] => [{"drugName":"LOPROX","activeIngredients":"CICLOPIROX","strength":"1%","dosageForm":"SHAMPOO;TOPICAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/08\/2013","submission":"SUPPL-20","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021159s020lbl.pdf\"}]","notes":""},{"actionDate":"12\/06\/2012","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021159s019lbl.pdf\"}]","notes":""},{"actionDate":"06\/12\/2006","submission":"SUPPL-9","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021159s009lbl.pdf\"}]","notes":""},{"actionDate":"02\/28\/2003","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/021159lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"LOPROX","submission":"CICLOPIROX","actionType":"1%","submissionClassification":"SHAMPOO;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2013-05-08
        )

)