TAKEDA PHARMS USA FDA Approval NDA 021925

NDA 021925

TAKEDA PHARMS USA

FDA Drug Application

Application #021925

Documents

Letter2007-02-12
Letter2009-10-26
Letter2010-09-28
Letter2011-08-04
Letter2012-05-22
Label2007-09-07
Label2007-10-04
Label2009-01-06
Label2013-11-14
Label2011-08-04
Label2013-11-14
Review2008-09-04
Other Important Information from FDA2007-08-15
Letter2006-08-04
Letter2007-09-11
Letter2007-10-04
Letter2007-10-04
Letter2009-01-06
Letter2013-11-14
Letter2011-08-04
Letter2013-11-14
Letter2015-03-17
Label2006-08-04
Label2007-02-23
Label2007-09-26
Label2010-09-29
Label2011-08-04
Label2015-03-19
Letter2016-12-13
Label2017-12-26
Medication Guide2017-12-26
Letter2017-12-27

Application Sponsors

NDA 021925TAKEDA PHARMS USA

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL2MG;30MG1DUETACTGLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE
002TABLET;ORAL4MG;30MG1DUETACTGLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE

FDA Submissions

TYPE 4; Type 4 - New CombinationORIG1AP2006-07-28STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2007-09-06N/A
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2007-10-01N/A
LABELING; LabelingSUPPL4AP2007-09-26STANDARD
LABELING; LabelingSUPPL5AP2009-01-04STANDARD
LABELING; LabelingSUPPL6AP2013-11-12STANDARD
LABELING; LabelingSUPPL7AP2009-09-09STANDARD
LABELING; LabelingSUPPL8AP2010-09-23UNKNOWN
REMS; REMSSUPPL10AP2011-08-04N/A
LABELING; LabelingSUPPL11AP2011-08-04901 REQUIRED
REMS; REMSSUPPL12AP2012-05-17N/A
MANUF (CMC); Manufacturing (CMC)SUPPL13AP2013-07-22STANDARD
LABELING; LabelingSUPPL14AP2013-11-12STANDARD
LABELING; LabelingSUPPL15AP2015-03-16STANDARD
EFFICACY; EfficacySUPPL16AP2016-12-12STANDARD
LABELING; LabelingSUPPL17AP2017-12-21STANDARD

Submissions Property Types

ORIG1Null31
SUPPL5Null31
SUPPL6Null7
SUPPL7Null31
SUPPL8Null6
SUPPL10Null6
SUPPL11Null6
SUPPL12Null6
SUPPL13Null0
SUPPL14Null6
SUPPL15Null6
SUPPL16Null4
SUPPL17Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

TAKEDA PHARMS USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21925
            [companyName] => TAKEDA PHARMS USA
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2017\/021925s017lbl.pdf#page=39"]
            [products] => [{"drugName":"DUETACT","activeIngredients":"GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE","strength":"2MG;30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"DUETACT","activeIngredients":"GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE","strength":"4MG;30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"12\/21\/2017","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021925s017lbl.pdf\"}]","notes":""},{"actionDate":"03\/16\/2015","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021925s015lbl.pdf\"}]","notes":""},{"actionDate":"11\/12\/2013","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021925s006s014lbl.pdf\"}]","notes":""},{"actionDate":"11\/12\/2013","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021925s006s014lbl.pdf\"}]","notes":""},{"actionDate":"08\/04\/2011","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021925s010s011lbl.pdf\"}]","notes":""},{"actionDate":"08\/04\/2011","submission":"SUPPL-11","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021925s010s011lbl.pdf\"}]","notes":""},{"actionDate":"08\/04\/2011","submission":"SUPPL-10","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021925s010s011lbl.pdf\"}]","notes":""},{"actionDate":"09\/23\/2010","submission":"SUPPL-8","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021925s008lbl.pdf\"}]","notes":""},{"actionDate":"01\/04\/2009","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021925s005lbl.pdf\"}]","notes":""},{"actionDate":"10\/01\/2007","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021925s003lbl.pdf\"}]","notes":""},{"actionDate":"10\/01\/2007","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021925s003lbl.pdf\"}]","notes":""},{"actionDate":"09\/26\/2007","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021925s004lbl.pdf\"}]","notes":""},{"actionDate":"09\/06\/2007","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021925s002lbl.pdf\"}]","notes":""},{"actionDate":"09\/06\/2007","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021925s002lbl.pdf\"}]","notes":""},{"actionDate":"02\/06\/2007","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021925s001lbl.pdf\"}]","notes":""},{"actionDate":"07\/28\/2006","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021925lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"DUETACT","submission":"GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE","actionType":"2MG;30MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"DUETACT","submission":"GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE","actionType":"4MG;30MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-12-21
        )

)
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