BAYER HEALTHCARE LLC FDA Approval NDA 021891

NDA 021891

BAYER HEALTHCARE LLC

FDA Drug Application

Application #021891

Documents

Letter2008-10-23
Letter2010-06-29
Letter2014-07-28
Letter2015-12-29
Letter2016-04-07
Label2016-02-11
Label2016-04-11
Letter2006-09-18
Letter2008-10-09
Label2006-09-15
Label2014-07-29
Review2008-07-09
Letter2017-05-25
Label2017-05-25
Letter2018-02-23
Label2018-03-15
Letter2018-07-23
Label2018-08-03
Letter2018-12-12
Label2018-12-30
Label2019-01-04
Letter2019-01-04
Label2019-06-18
Letter2019-06-18
Label2019-10-07
Letter2019-10-07
Label2019-12-11
Letter2019-12-11
Letter2020-08-10
Letter2021-01-08
Label2021-03-04
Letter2021-04-06
Label2021-04-28
Label2021-07-21
Letter2022-12-28
Label2023-01-03

Application Sponsors

NDA 021891BAYER HEALTHCARE LLC

Marketing Status

Over-the-counter001
Over-the-counter002

Application Products

001TABLET, CHEWABLE;ORAL5MG1CHILDREN'S CLARITINLORATADINE
002TABLET, CHEWABLE;ORAL10MG1CLARITINLORATADINE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2006-08-23STANDARD
LABELING; LabelingSUPPL4AP2008-10-21STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP2008-10-08STANDARD
TYPE 3; Type 3 - New Dosage FormSUPPL8AP2010-03-03STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL15AP2013-01-04STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL16AP2013-03-26STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL17AP2013-09-10STANDARD
LABELING; LabelingSUPPL18AP2014-07-25STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL19AP2015-09-24N/A
LABELING; LabelingSUPPL20AP2015-12-23STANDARD
LABELING; LabelingSUPPL21AP2016-04-05STANDARD
LABELING; LabelingSUPPL23AP2017-05-22STANDARD
LABELING; LabelingSUPPL26AP2018-02-15STANDARD
LABELING; LabelingSUPPL27AP2018-07-20STANDARD
LABELING; LabelingSUPPL28AP2019-01-03STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL29AP2018-11-21N/A
LABELING; LabelingSUPPL31AP2019-06-17STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL32AP2019-11-07N/A
LABELING; LabelingSUPPL33AP2019-10-03STANDARD
LABELING; LabelingSUPPL34AP2020-08-07STANDARD
LABELING; LabelingSUPPL36AP2021-01-07STANDARD
LABELING; LabelingSUPPL38AP2021-04-02STANDARD
LABELING; LabelingSUPPL43AP2022-12-27STANDARD

Submissions Property Types

SUPPL5Null0
SUPPL8Null0
SUPPL15Null0
SUPPL16Null0
SUPPL17Null0
SUPPL18Null15
SUPPL19Null6
SUPPL20Null6
SUPPL21Null7
SUPPL23Null7
SUPPL26Null6
SUPPL27Null6
SUPPL28Null7
SUPPL29Null15
SUPPL31Null7
SUPPL32Null7
SUPPL33Null15
SUPPL34Null6
SUPPL36Null15
SUPPL38Null15
SUPPL43Null6

CDER Filings

BAYER HEALTHCARE LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21891
            [companyName] => BAYER HEALTHCARE LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHILDREN'S CLARITIN","activeIngredients":"LORATADINE","strength":"5MG","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"CLARITIN","activeIngredients":"LORATADINE","strength":"10MG","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"11\/07\/2019","submission":"SUPPL-32","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021891Orig1s032lbl.pdf\"}]","notes":""},{"actionDate":"10\/03\/2019","submission":"SUPPL-33","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021891Orig1s033lbl.pdf\"}]","notes":""},{"actionDate":"06\/17\/2019","submission":"SUPPL-31","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021891Orig1s031lbl.pdf\"}]","notes":""},{"actionDate":"01\/03\/2019","submission":"SUPPL-28","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021891Orig1s028lbl.pdf\"}]","notes":""},{"actionDate":"11\/21\/2018","submission":"SUPPL-29","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021891Orig1s029lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"07\/20\/2018","submission":"SUPPL-27","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021891Orig1s027Lbl.pdf\"}]","notes":""},{"actionDate":"02\/15\/2018","submission":"SUPPL-26","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021891Orig1s026lbl.pdf\"}]","notes":""},{"actionDate":"05\/22\/2017","submission":"SUPPL-23","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021891Orig1s023lbl.pdf\"}]","notes":""},{"actionDate":"04\/05\/2016","submission":"SUPPL-21","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021891Orig1s021lbl.pdf\"}]","notes":""},{"actionDate":"12\/23\/2015","submission":"SUPPL-20","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021891Orig1s020lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/2014","submission":"SUPPL-18","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021891Orig1s018lbl.pdf\"}]","notes":""},{"actionDate":"08\/23\/2006","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021891lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CHILDREN'S CLARITIN","submission":"LORATADINE","actionType":"5MG","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"},{"actionDate":"CLARITIN","submission":"LORATADINE","actionType":"10MG","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-11-07
        )

)
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