TAKEDA PHARMS USA FDA Approval NDA 021842

NDA 021842

TAKEDA PHARMS USA

FDA Drug Application

Application #021842

Documents

Letter2006-11-07
Letter2012-05-18
Letter2009-11-25
Letter2011-08-04
Letter2014-08-19
Label2006-09-01
Label2009-01-06
Label2012-05-22
Label2009-10-23
Label2011-08-04
Patient Package Insert2005-08-30
Letter2005-08-31
Letter2006-09-18
Letter2006-10-02
Letter2007-10-04
Letter2009-01-06
Letter2012-05-18
Letter2009-10-26
Letter2010-08-11
Letter2011-08-04
Letter2012-05-22
Label2005-08-30
Label2006-11-06
Label2007-09-26
Label2012-05-22
Label2011-08-04
Label2014-08-20
Review2007-01-22
Other Important Information from FDA2009-11-12
Letter2016-12-13
Letter2016-12-14
Label2017-01-09
Label2017-01-09
Label2017-12-26
Medication Guide2017-12-26
Letter2017-12-27

Application Sponsors

NDA 021842TAKEDA PHARMS USA

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL500MG;EQ 15MG BASE1ACTOPLUS METMETFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
002TABLET;ORAL850MG;EQ 15MG BASE1ACTOPLUS METMETFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

FDA Submissions

TYPE 4; Type 4 - New CombinationORIG1AP2005-08-29STANDARD
LABELING; LabelingSUPPL2AP2006-11-04STANDARD
LABELING; LabelingSUPPL3AP2006-09-28STANDARD
LABELING; LabelingSUPPL5AP2007-09-26STANDARD
LABELING; LabelingSUPPL7AP2009-01-04STANDARD
LABELING; LabelingSUPPL8AP2012-05-17STANDARD
LABELING; LabelingSUPPL9AP2009-09-14STANDARD
EFFICACY; EfficacySUPPL10AP2012-05-17STANDARD
REMS; REMSSUPPL11AP2009-10-21UNKNOWN
LABELING; LabelingSUPPL12AP2010-08-06STANDARD
REMS; REMSSUPPL14AP2011-08-04N/A
LABELING; LabelingSUPPL15AP2011-08-04901 REQUIRED
REMS; REMSSUPPL16AP2012-05-17N/A
MANUF (CMC); Manufacturing (CMC)SUPPL18AP2013-08-15STANDARD
LABELING; LabelingSUPPL19AP2014-08-16STANDARD
EFFICACY; EfficacySUPPL20AP2016-12-12STANDARD
LABELING; LabelingSUPPL21AP2016-12-12901 REQUIRED
LABELING; LabelingSUPPL22AP2017-12-21STANDARD

Submissions Property Types

ORIG1Null31
SUPPL3Null31
SUPPL5Null31
SUPPL7Null31
SUPPL8Null7
SUPPL9Null7
SUPPL10Null15
SUPPL11Null6
SUPPL12Null6
SUPPL14Null6
SUPPL15Null6
SUPPL16Null6
SUPPL18Null0
SUPPL19Null15
SUPPL20Null6
SUPPL21Null6
SUPPL22Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

TAKEDA PHARMS USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21842
            [companyName] => TAKEDA PHARMS USA
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2017\/021842s022lbl.pdf#page=41"]
            [products] => [{"drugName":"ACTOPLUS MET","activeIngredients":"METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE","strength":"500MG;EQ 15MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"ACTOPLUS MET","activeIngredients":"METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE","strength":"850MG;EQ 15MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/21\/2017","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021842s022lbl.pdf\"}]","notes":""},{"actionDate":"12\/12\/2016","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021842s20-21lbl.pdf\"}]","notes":""},{"actionDate":"12\/12\/2016","submission":"SUPPL-20","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021842s20-21lbl.pdf\"}]","notes":""},{"actionDate":"08\/16\/2014","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021842s019lbl.pdf\"}]","notes":""},{"actionDate":"05\/17\/2012","submission":"SUPPL-10","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021842s008s010lbl.pdf\"}]","notes":""},{"actionDate":"05\/17\/2012","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021842s008s010lbl.pdf\"}]","notes":""},{"actionDate":"08\/04\/2011","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021842s014s015lbl.pdf\"}]","notes":""},{"actionDate":"08\/04\/2011","submission":"SUPPL-15","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021842s014s015lbl.pdf\"}]","notes":""},{"actionDate":"08\/04\/2011","submission":"SUPPL-14","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021842s014s015lbl.pdf\"}]","notes":""},{"actionDate":"10\/21\/2009","submission":"SUPPL-11","supplementCategories":"REMS-Assessment","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021842s011lbl.pdf\"}]","notes":""},{"actionDate":"01\/04\/2009","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021842s007lbl.pdf\"}]","notes":""},{"actionDate":"09\/26\/2007","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021842s005lbl.pdf\"}]","notes":""},{"actionDate":"11\/04\/2006","submission":"SUPPL-2","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021073s028,021842s002lbl.pdf\"}]","notes":""},{"actionDate":"08\/30\/2006","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021842s001lbl.pdf\"}]","notes":""},{"actionDate":"08\/29\/2005","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021842lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ACTOPLUS MET","submission":"METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE","actionType":"500MG;EQ 15MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ACTOPLUS MET","submission":"METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE","actionType":"850MG;EQ 15MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-12-21
        )

)
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