NDA 208288

3M HEALTH CARE

FDA Drug Application

Application #208288

Documents

• Label: 2018-08-08
• Letter: 2018-08-10
• Review: 2019-04-05
• Letter: 2023-01-23
• Label: 2023-01-23

Application Sponsors

NDA 208288

3M HEALTH CARE

Marketing Status

• Over-the-counter: 001

Application Products

001

SOLUTION;TOPICAL

2%;70%

1

SOLUPREP

CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2018-08-08	STANDARD
EFFICACY; Efficacy	SUPPL	4	AP	2023-01-20	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	4	Null	6

CDER Filings

3M HEALTH CARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208288
            [companyName] => 3M HEALTH CARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"SOLUPREP","activeIngredients":"CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL","strength":"2%;70%","dosageForm":"SOLUTION;TOPICAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"08\/08\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208288s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/08\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208288s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208288Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/208288Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2018-08-08
        )

)