BAYER HEALTHCARE LLC FDA Approval NDA 022015

NDA 022015

BAYER HEALTHCARE LLC

FDA Drug Application

Application #022015

Documents

Letter2008-12-04
Letter2010-05-07
Letter2012-03-19
Letter2015-11-16
Label2015-11-04
Label2015-11-19
Review2007-06-22
Letter2006-10-13
Letter2008-11-21
Letter2014-08-06
Letter2015-11-04
Label2014-08-04
Letter2016-10-05
Label2016-10-11
Letter2016-10-25
Label2016-10-27
Letter2017-10-06
Label2017-10-18
Letter2018-04-27
Label2018-05-03
Letter2018-05-08
Label2018-05-08
Letter2018-08-20
Label2018-08-27
Label2018-10-15
Letter2018-10-17
Label2019-06-05
Letter2019-06-05
Letter2021-04-28
Label2021-05-14
Letter2022-07-06
Label2022-07-05

Application Sponsors

NDA 022015BAYER HEALTHCARE LLC

Marketing Status

Over-the-counter001

Application Products

001FOR SOLUTION;ORAL17GM/SCOOPFUL1MIRALAXPOLYETHYLENE GLYCOL 3350

FDA Submissions

TYPE 8; Type 8 - Partial Rx to OTC SwitchORIG1AP2006-10-06STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2008-11-20N/A
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2008-12-02N/A
LABELING; LabelingSUPPL6AP2010-05-05STANDARD
LABELING; LabelingSUPPL12AP2012-03-15STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL16AP2013-01-04STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL17AP2013-10-22STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL18AP2015-09-24STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL19AP2014-03-05STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL20AP2014-08-03STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL22AP2015-07-14STANDARD
LABELING; LabelingSUPPL23AP2015-10-29STANDARD
LABELING; LabelingSUPPL24AP2015-11-12STANDARD
LABELING; LabelingSUPPL25AP2016-09-30STANDARD
LABELING; LabelingSUPPL26AP2016-10-21STANDARD
LABELING; LabelingSUPPL27AP2017-10-04STANDARD
LABELING; LabelingSUPPL29AP2018-04-24STANDARD
LABELING; LabelingSUPPL30AP2018-05-04STANDARD
LABELING; LabelingSUPPL33AP2018-08-17STANDARD
LABELING; LabelingSUPPL34AP2018-10-12STANDARD
LABELING; LabelingSUPPL35AP2019-06-03STANDARD
LABELING; LabelingSUPPL40AP2021-04-27STANDARD
LABELING; LabelingSUPPL43AP2022-07-05STANDARD

Submissions Property Types

SUPPL6Null6
SUPPL12Null7
SUPPL16Null0
SUPPL17Null0
SUPPL18Null0
SUPPL19Null0
SUPPL20Null0
SUPPL22Null0
SUPPL23Null6
SUPPL24Null6
SUPPL25Null6
SUPPL26Null7
SUPPL27Null15
SUPPL29Null7
SUPPL30Null15
SUPPL33Null7
SUPPL34Null7
SUPPL35Null15
SUPPL40Null7
SUPPL43Null6

CDER Filings

BAYER HEALTHCARE LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22015
            [companyName] => BAYER HEALTHCARE LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MIRALAX","activeIngredients":"POLYETHYLENE GLYCOL 3350","strength":"17GM\/SCOOPFUL","dosageForm":"FOR SOLUTION;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/03\/2019","submission":"SUPPL-35","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022015Orig1s035lbl.pdf\"}]","notes":""},{"actionDate":"10\/12\/2018","submission":"SUPPL-34","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022015Orig1s034Lbl.pdf\"}]","notes":""},{"actionDate":"08\/17\/2018","submission":"SUPPL-33","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022015Orig1s0333Lbl.pdf\"}]","notes":""},{"actionDate":"05\/04\/2018","submission":"SUPPL-30","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022015Orig1s030lbl.pdf\"}]","notes":""},{"actionDate":"04\/24\/2018","submission":"SUPPL-29","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022015Orig1s029lbl.pdf\"}]","notes":""},{"actionDate":"10\/04\/2017","submission":"SUPPL-27","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022015Orig1s027lbl.pdf\"}]","notes":""},{"actionDate":"10\/21\/2016","submission":"SUPPL-26","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022015Orig1s026lbl.pdf\"}]","notes":""},{"actionDate":"09\/30\/2016","submission":"SUPPL-25","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022015Orig1s025lbl.pdf\"}]","notes":""},{"actionDate":"11\/12\/2015","submission":"SUPPL-24","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022015Orig1s024lbl.pdf\"}]","notes":""},{"actionDate":"10\/29\/2015","submission":"SUPPL-23","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022015Orig1s023lbl.pdf\"}]","notes":""},{"actionDate":"08\/03\/2014","submission":"SUPPL-20","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022015Orig1s020lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."}]
            [originalApprovals] => [{"actionDate":"MIRALAX","submission":"POLYETHYLENE GLYCOL 3350","actionType":"17GM\/SCOOPFUL","submissionClassification":"FOR SOLUTION;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-06-03
        )

)
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