BAYER HEALTHCARE LLC FDA Approval NDA 020641

NDA 020641

BAYER HEALTHCARE LLC

FDA Drug Application

Application #020641

Documents

Letter2000-12-04
Letter2004-10-29
Letter2005-06-15
Letter2013-03-01
Letter2015-04-22
Letter2015-11-09
Letter2015-12-31
Label2000-12-04
Label2015-04-21
Label2016-01-04
Review2007-03-02
Review2000-12-04
Letter2002-11-27
Letter2003-11-25
Letter2004-07-21
Letter2008-07-30
Letter2008-07-30
Letter2015-10-23
Label2014-01-14
Label2015-10-26
Label2015-11-25
Review2007-03-02
Review2004-12-07
Letter2016-08-09
Label2016-08-22
Letter2018-05-16
Label2018-05-23
Letter2019-03-01
Label2019-03-01

Application Sponsors

NDA 020641BAYER HEALTHCARE LLC

Marketing Status

Over-the-counter002
Discontinued003

Application Products

002SYRUP;ORAL1MG/ML1CLARITINLORATADINE
003SYRUP;ORAL1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**1CLARITIN HIVES RELIEFLORATADINE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1996-10-10STANDARD
LABELING; LabelingSUPPL2AP1998-03-30STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1998-10-29STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1999-01-07STANDARD
EFFICACY; EfficacySUPPL7AP2000-12-04STANDARD
EFFICACY; EfficacySUPPL9AP2002-11-27STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL10AP2002-07-23STANDARD
EFFICACY; EfficacySUPPL11AP2003-11-19STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL12AP2002-12-09STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL16AP2004-07-15STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL17AP2004-10-27STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL18AP2005-06-14STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL24AP2008-07-25N/A
LABELING; LabelingSUPPL25AP2008-07-25STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL30AP2012-11-20STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL32AP2013-02-28STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL33AP2013-04-16STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL35AP2014-05-15STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL36AP2015-04-16STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL37AP2015-10-21N/A
LABELING; LabelingSUPPL38AP2015-11-12STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL39AP2015-12-10STANDARD
LABELING; LabelingSUPPL40AP2015-12-30STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL41AP2016-02-12STANDARD
LABELING; LabelingSUPPL42AP2016-08-09STANDARD
LABELING; LabelingSUPPL45AP2018-05-14STANDARD
LABELING; LabelingSUPPL46AP2019-02-28STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL3Null0
SUPPL6Null0
SUPPL10Null0
SUPPL12Null0
SUPPL16Null0
SUPPL17Null0
SUPPL18Null0
SUPPL30Null0
SUPPL32Null0
SUPPL33Null0
SUPPL35Null0
SUPPL36Null0
SUPPL37Null15
SUPPL38Null6
SUPPL39Null0
SUPPL40Null6
SUPPL41Null0
SUPPL42Null15
SUPPL45Null7
SUPPL46Null15

CDER Filings

BAYER HEALTHCARE LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20641
            [companyName] => BAYER HEALTHCARE LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLARITIN","activeIngredients":"LORATADINE","strength":"1MG\/ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"CLARITIN HIVES RELIEF","activeIngredients":"LORATADINE","strength":"1MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"SYRUP;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"02\/28\/2019","submission":"SUPPL-46","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020641Orig1s046lbl.pdf\"}]","notes":""},{"actionDate":"05\/14\/2018","submission":"SUPPL-45","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020641Orig1s045lbl.pdf\"}]","notes":""},{"actionDate":"08\/09\/2016","submission":"SUPPL-42","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020641Orig1s042lbl.pdf\"}]","notes":""},{"actionDate":"12\/30\/2015","submission":"SUPPL-40","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020641Orig1s040lbl.pdf\"}]","notes":""},{"actionDate":"11\/12\/2015","submission":"SUPPL-38","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020641Orig1s038lbl.pdf\"}]","notes":""},{"actionDate":"10\/21\/2015","submission":"SUPPL-37","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020641s037lbl.pdf\"}]","notes":""},{"actionDate":"04\/16\/2015","submission":"SUPPL-36","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020641Orig1s036lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"02\/28\/2013","submission":"SUPPL-32","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020641Orig1s032lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"12\/04\/2000","submission":"SUPPL-7","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/20641s7lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CLARITIN","submission":"LORATADINE","actionType":"1MG\/ML","submissionClassification":"SYRUP;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"},{"actionDate":"CLARITIN HIVES RELIEF","submission":"LORATADINE","actionType":"1MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"SYRUP;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-02-28
        )

)
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.