NDA 207964

MEDLINE INDUSTRIES

FDA Drug Application

Application #207964

Documents

• Label: 2018-12-04
• Letter: 2019-01-31
• Review: 2019-06-10

Application Sponsors

NDA 207964

MEDLINE INDUSTRIES

Marketing Status

• Over-the-counter: 001

Application Products

001

CLOTH;TOPICAL

2%

0

READYPREP CHG

CHLORHEXIDINE GLUCONATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2018-11-20

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

MEDLINE INDUSTRIES

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(
    [0] => Array
        (
            [ApplNo] => 207964
            [companyName] => MEDLINE INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"READYPREP CHG","activeIngredients":"CHLORHEXIDINE GLUCONATE","strength":"2%","dosageForm":"CLOTH;TOPICAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/20\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/207964Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/20\/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\\\/207964Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/207964Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/207964Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2018-11-20
        )

)