DAIICHI SANKYO FDA Approval NDA 021176

NDA 021176

DAIICHI SANKYO

FDA Drug Application

Application #021176

Documents

Letter2004-06-30
Letter2002-10-17
Letter2003-10-16
Letter2003-11-25
Letter2006-09-18
Letter2008-01-23
Letter2008-06-06
Letter2009-10-26
Letter2010-09-16
Letter2012-01-17
Letter2012-07-13
Letter2014-01-23
Letter2013-07-02
Label2003-03-05
Label2003-10-16
Label2007-08-30
Label2009-10-07
Label2010-09-20
Label2012-07-13
Label2013-07-02
Letter2004-06-30
Letter2003-08-28
Letter2006-07-13
Letter2007-08-30
Letter2011-07-19
Letter2013-07-02
Label2004-06-30
Label2002-10-17
Label2003-08-28
Label2003-12-02
Label2006-09-12
Label2006-07-13
Label2008-01-23
Label2011-07-18
Label2012-01-06
Label2014-01-23
Label2013-07-02
Review2002-04-11
Pediatric Written Request2004-08-31
Pediatric Amendment 12006-01-19
Pediatric Amendment 22006-03-28
Pediatric Amendment 32007-04-02
Pediatric Medical Review1900-01-01
Pediatric Statistical Review1900-01-01
Pediatric Written Request1900-01-01
Label2019-01-17
Letter2019-01-22
Label2019-05-22
Letter2019-05-16
Letter2020-05-13
Label2020-05-13
Letter2020-07-30
Label2020-07-30
Label2021-10-21
Letter2021-10-21

Application Sponsors

NDA 021176DAIICHI SANKYO

Marketing Status

Prescription001

Application Products

001TABLET;ORAL625MG1WELCHOLCOLESEVELAM HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2000-05-26STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2001-05-03STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2002-05-10STANDARD
LABELING; LabelingSUPPL4AP2003-02-11STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP2002-10-17STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP2002-08-08STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2003-08-21STANDARD
LABELING; LabelingSUPPL9AP2003-10-10STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL10AP2003-11-17STANDARD
EFFICACY; EfficacySUPPL14AP2006-09-06STANDARD
LABELING; LabelingSUPPL15AP2006-07-10STANDARD
EFFICACY; EfficacySUPPL17AP2008-01-18UNKNOWN
LABELING; LabelingSUPPL19AP2007-08-27STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL21AP2008-05-30N/A
EFFICACY; EfficacySUPPL22AP2009-10-02PRIORITY
LABELING; LabelingSUPPL27AP2010-09-14UNKNOWN
LABELING; LabelingSUPPL28AP2011-07-18UNKNOWN
LABELING; LabelingSUPPL29AP2012-01-03UNKNOWN
LABELING; LabelingSUPPL30AP2012-07-09UNKNOWN
EFFICACY; EfficacySUPPL34AP2013-06-28STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL35AP2013-04-22STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL36AP2013-02-25STANDARD
EFFICACY; EfficacySUPPL37AP2014-01-22STANDARD
LABELING; LabelingSUPPL38AP2013-06-28STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL39AP2014-05-20STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL40AP2016-07-14STANDARD
LABELING; LabelingSUPPL44AP2019-01-16STANDARD
LABELING; LabelingSUPPL45AP2019-05-21STANDARD
LABELING; LabelingSUPPL47AP2020-05-12STANDARD
LABELING; LabelingSUPPL48AP2020-07-29STANDARD
LABELING; LabelingSUPPL49AP2021-10-20STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL5Null0
SUPPL6Null0
SUPPL8Null0
SUPPL10Null0
SUPPL22Null7
SUPPL27Null7
SUPPL28Null6
SUPPL29Null6
SUPPL30Null7
SUPPL34Null15
SUPPL35Null0
SUPPL36Null0
SUPPL37Null15
SUPPL38Null6
SUPPL39Null0
SUPPL40Null0
SUPPL44Null15
SUPPL45Null6
SUPPL47Null6
SUPPL48Null6
SUPPL49Null7

TE Codes

001PrescriptionAB

CDER Filings

DAIICHI SANKYO
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21176
            [companyName] => DAIICHI SANKYO
            [docInserts] => ["",""]
            [products] => [{"drugName":"WELCHOL","activeIngredients":"COLESEVELAM HYDROCHLORIDE","strength":"625MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/29\/2020","submission":"SUPPL-48","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022362s028,021176s048lbl.pdf\"}]","notes":""},{"actionDate":"05\/12\/2020","submission":"SUPPL-47","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022362s027,021776s047,210895s001lbl.pdf\"}]","notes":""},{"actionDate":"05\/21\/2019","submission":"SUPPL-45","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021176s045,022362s025lbl.pdf\"}]","notes":""},{"actionDate":"01\/16\/2019","submission":"SUPPL-44","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021176s044,022362s023lbl.pdf\"}]","notes":""},{"actionDate":"01\/22\/2014","submission":"SUPPL-37","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021176s037,022362s020lbl.pdf\"}]","notes":""},{"actionDate":"06\/28\/2013","submission":"SUPPL-38","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021176s034s038,022362s015s017s018lbl.pdf\"}]","notes":""},{"actionDate":"06\/28\/2013","submission":"SUPPL-34","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021176s028lbl.pdf\"}]","notes":""},{"actionDate":"09\/14\/2010","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021176s027,022362s002lbl.pdf\"}]","notes":""},{"actionDate":"10\/02\/2009","submission":"SUPPL-22","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022362lbl.pdf\"}]","notes":""},{"actionDate":"01\/18\/2008","submission":"SUPPL-17","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021176s017lbl.pdf\"}]","notes":""},{"actionDate":"08\/27\/2007","submission":"SUPPL-19","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021176s019lbl.pdf\"}]","notes":""},{"actionDate":"09\/06\/2006","submission":"SUPPL-14","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021176s014lbl.pdf\"}]","notes":""},{"actionDate":"07\/10\/2006","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021176s015lbl.pdf\"}]","notes":""},{"actionDate":"11\/17\/2003","submission":"SUPPL-10","supplementCategories":"Manufacturing (CMC)-Control","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/21176scs010_welchol_lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"10\/10\/2003","submission":"SUPPL-9","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/21176slr009_welChol_lbl.pdf\"}]","notes":""},{"actionDate":"08\/21\/2003","submission":"SUPPL-8","supplementCategories":"Manufacturing (CMC)-Control","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/21176scs008_welchol_lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"02\/11\/2003","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/021176s004lbl.pdf\"}]","notes":""},{"actionDate":"10\/17\/2002","submission":"SUPPL-5","supplementCategories":"Manufacturing (CMC)-Packaging","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21176s5lbl.pdf\"}]","notes":""},{"actionDate":"05\/26\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2000\\\/21-141_Welchol_prntlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"WELCHOL","submission":"COLESEVELAM HYDROCHLORIDE","actionType":"625MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-07-29
        )

)
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