NDA 022483

BAUSCH

FDA Drug Application

Application #022483

Documents

• Letter: 2010-03-29
• Letter: 2011-03-25
• Letter: 2011-10-03
• Letter: 2011-07-19
• Label: 2011-02-18
• Label: 2011-03-28
• Label: 2011-07-18
• Label: 2012-02-17
• Review: 2010-12-01
• Summary Review: 2011-02-17
• Letter: 2012-02-17
• Label: 2011-09-30

Application Sponsors

NDA 022483

BAUSCH

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CREAM;TOPICAL	3.75%	1	ZYCLARA	IMIQUIMOD
002	CREAM;TOPICAL	2.5%	1	ZYCLARA	IMIQUIMOD

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2010-03-25	STANDARD
LABELING; Labeling	SUPPL	2	AP	2011-09-29	UNKNOWN
EFFICACY; Efficacy	SUPPL	3	AP	2011-07-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2012-02-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2014-11-24	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	6
SUPPL	3	Null	6
SUPPL	6	Null	0
SUPPL	7	Null	0

TE Codes

001

Prescription

AB

CDER Filings

BAUSCH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22483
            [companyName] => BAUSCH
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZYCLARA","activeIngredients":"IMIQUIMOD","strength":"3.75%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"ZYCLARA","activeIngredients":"IMIQUIMOD","strength":"2.5%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"02\/14\/2012","submission":"SUPPL-6","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022483s006lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"09\/29\/2011","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022483s002lbl.pdf\"}]","notes":""},{"actionDate":"07\/15\/2011","submission":"SUPPL-3","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022483s003lbl.pdf\"}]","notes":""},{"actionDate":"03\/24\/2011","submission":"SUPPL-1","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/201153s000,022483s001lbl.pdf\"}]","notes":""},{"actionDate":"03\/25\/2010","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2010\\\/022483Orig1s000Lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ZYCLARA","submission":"IMIQUIMOD","actionType":"3.75%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ZYCLARA","submission":"IMIQUIMOD","actionType":"2.5%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2012-02-14
        )

)