SHIRE LLC FDA Approval NDA 021468

NDA 021468

SHIRE LLC

FDA Drug Application

Application #021468

Documents

Letter2004-10-29
Letter2008-10-28
Letter2011-04-29
Letter2011-09-07
Letter2016-02-26
Label2004-11-01
Label2011-04-29
Label2011-09-07
Label2012-11-02
Review2005-01-28
Review2011-01-04
Letter2006-03-23
Letter2008-04-11
Letter2011-04-29
Letter2012-11-05
Letter2014-09-26
Label2011-04-29
Label2014-09-26
Label2016-02-26
Review2011-01-04
Medication Guide2018-11-08
Label2018-11-12
Medication Guide2018-11-12
Letter2018-12-07
Letter2020-05-12
Label2020-05-12
Medication Guide2020-05-12

Application Sponsors

NDA 021468SHIRE LLC

Marketing Status

Discontinued001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET, CHEWABLE;ORALEQ 250MG BASE0FOSRENOLLANTHANUM CARBONATE
002TABLET, CHEWABLE;ORALEQ 500MG BASE1FOSRENOLLANTHANUM CARBONATE
003TABLET, CHEWABLE;ORALEQ 750MG BASE1FOSRENOLLANTHANUM CARBONATE
004TABLET, CHEWABLE;ORALEQ 1GM BASE1FOSRENOLLANTHANUM CARBONATE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2004-10-26STANDARD
LABELING; LabelingSUPPL4AP2006-03-03STANDARD
LABELING; LabelingSUPPL5AP2006-03-03STANDARD
LABELING; LabelingSUPPL10AP2008-04-10STANDARD
LABELING; LabelingSUPPL11AP2008-10-23STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL12AP2008-10-02N/A
LABELING; LabelingSUPPL14AP2011-04-27UNKNOWN
LABELING; LabelingSUPPL15AP2011-04-27UNKNOWN
LABELING; LabelingSUPPL16AP2011-09-02UNKNOWN
LABELING; LabelingSUPPL18AP2012-10-31UNKNOWN
LABELING; LabelingSUPPL19AP2014-09-24STANDARD
LABELING; LabelingSUPPL20AP2016-02-24STANDARD
LABELING; LabelingSUPPL21AP2018-11-08STANDARD
LABELING; LabelingSUPPL23AP2020-05-11STANDARD

Submissions Property Types

SUPPL4Null0
SUPPL14Null6
SUPPL15Null6
SUPPL16Null6
SUPPL18Null7
SUPPL19Null7
SUPPL20Null7
SUPPL21Null15
SUPPL23Null15

TE Codes

002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

TAKEDA PHARMS USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21468
            [companyName] => TAKEDA PHARMS USA
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/021468s023,204734s005lbl.pdf#page=12"]
            [products] => [{"drugName":"FOSRENOL","activeIngredients":"LANTHANUM CARBONATE","strength":"EQ 250MG BASE","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FOSRENOL","activeIngredients":"LANTHANUM CARBONATE","strength":"EQ 500MG BASE","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"FOSRENOL","activeIngredients":"LANTHANUM CARBONATE","strength":"EQ 750MG BASE","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"FOSRENOL","activeIngredients":"LANTHANUM CARBONATE","strength":"EQ 1GM BASE","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/11\/2020","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021468s023,204734s005lbl.pdf\"}]","notes":""},{"actionDate":"11\/08\/2018","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021468s021,204734s003lbl.pdf\"}]","notes":""},{"actionDate":"02\/24\/2016","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021468s020,204734s001lbl.pdf\"}]","notes":""},{"actionDate":"09\/24\/2014","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021468s019lbl.pdf\"}]","notes":""},{"actionDate":"10\/31\/2012","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021468s018lbl.pdf\"}]","notes":""},{"actionDate":"09\/02\/2011","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021468s016lbl.pdf\"}]","notes":""},{"actionDate":"09\/02\/2011","submission":"SUPPL-16","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021468s016lbl.pdf\"}]","notes":""},{"actionDate":"04\/27\/2011","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021468s014s015lbl.pdf\"}]","notes":""},{"actionDate":"04\/27\/2011","submission":"SUPPL-14","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021468s014s015lbl.pdf\"}]","notes":""},{"actionDate":"10\/26\/2004","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21468lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"FOSRENOL","submission":"LANTHANUM CARBONATE","actionType":"EQ 250MG BASE","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"FOSRENOL","submission":"LANTHANUM CARBONATE","actionType":"EQ 500MG BASE","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"FOSRENOL","submission":"LANTHANUM CARBONATE","actionType":"EQ 750MG BASE","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"FOSRENOL","submission":"LANTHANUM CARBONATE","actionType":"EQ 1GM BASE","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-05-11
        )

)
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