TAKEDA PHARMS USA FDA Approval NDA 021073

NDA 021073

TAKEDA PHARMS USA

FDA Drug Application

Application #021073

Documents

Letter2002-07-12
Letter2002-01-07
Letter2002-12-03
Letter2003-12-04
Letter2004-08-05
Letter2004-07-21
Letter2006-09-18
Letter2006-11-07
Letter2007-08-17
Letter2008-05-09
Letter2009-10-26
Letter2010-07-30
Letter2011-08-05
Letter2013-11-14
Label1999-07-15
Label2003-06-22
Label2004-08-05
Label2004-07-21
Label2007-09-11
Label2011-02-09
Label2009-09-18
Label2011-08-04
Label2011-08-04
Review2007-09-13
Review2008-02-19
Review2007-09-13
Review2008-02-19
Review2008-02-19
Review2007-07-27
Review2007-07-09
Review2008-02-19
Review2007-11-19
Review2007-11-19
Letter1999-07-15
Letter2003-01-17
Letter2003-06-22
Letter2007-03-06
Letter2006-10-02
Letter2007-09-11
Letter2008-12-18
Letter2011-08-05
Letter2012-05-22
Label2002-07-12
Label2003-12-08
Label2007-03-07
Label2006-09-01
Label2006-11-06
Label2007-08-15
Label2009-01-02
Label2013-11-14
Review2000-06-30
Review2007-09-13
Review2007-09-13
Review2007-07-27
Review2008-02-19
Review2007-07-06
Review2008-07-31
Review2008-07-31
Patient Package Insert2008-06-12
Letter2016-12-13
Label2016-12-15
Label2017-12-26
Medication Guide2017-12-26
Letter2017-12-27

Application Sponsors

NDA 021073TAKEDA PHARMS USA

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORALEQ 15MG BASE1ACTOSPIOGLITAZONE HYDROCHLORIDE
002TABLET;ORALEQ 30MG BASE1ACTOSPIOGLITAZONE HYDROCHLORIDE
003TABLET;ORALEQ 45MG BASE1ACTOSPIOGLITAZONE HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1999-07-15PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2000-02-25PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2000-04-11PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL4AP2000-10-25PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL5AP2000-07-26PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL6AP2000-11-03PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL7AP2001-04-25PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2001-07-06PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2001-07-06PRIORITY
EFFICACY; EfficacySUPPL10AP2002-07-12STANDARD
LABELING; LabelingSUPPL11AP2001-07-02STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL12AP2001-05-22PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL13AP2002-10-01PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2001-08-03PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL15AP2002-02-28PRIORITY
LABELING; LabelingSUPPL16AP2002-01-07STANDARD
EFFICACY; EfficacySUPPL17AP2003-01-17STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL18AP2002-12-03PRIORITY
EFFICACY; EfficacySUPPL20AP2003-11-26STANDARD
LABELING; LabelingSUPPL21AP2003-06-11STANDARD
LABELING; LabelingSUPPL23AP2004-08-03STANDARD
LABELING; LabelingSUPPL24AP2004-07-20STANDARD
EFFICACY; EfficacySUPPL26AP2007-02-25STANDARD
LABELING; LabelingSUPPL27AP2006-08-30STANDARD
LABELING; LabelingSUPPL28AP2006-11-04STANDARD
LABELING; LabelingSUPPL29AP2006-09-28STANDARD
LABELING; LabelingSUPPL30AP2007-09-06STANDARD
LABELING; LabelingSUPPL31AP2007-08-14STANDARD
LABELING; LabelingSUPPL33AP2008-05-07STANDARD
LABELING; LabelingSUPPL34AP2008-12-11STANDARD
LABELING; LabelingSUPPL35AP2011-02-03STANDARD
LABELING; LabelingSUPPL37AP2009-09-09STANDARD
LABELING; LabelingSUPPL40AP2010-07-29STANDARD
REMS; REMSSUPPL43AP2011-08-04N/A
LABELING; LabelingSUPPL44AP2011-08-04901 REQUIRED
REMS; REMSSUPPL45AP2012-05-17N/A
LABELING; LabelingSUPPL46AP2013-11-12UNKNOWN
MANUF (CMC); Manufacturing (CMC)SUPPL47AP2013-06-27PRIORITY
EFFICACY; EfficacySUPPL48AP2016-12-12STANDARD
LABELING; LabelingSUPPL49AP2017-12-21STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL8Null0
SUPPL9Null0
SUPPL12Null0
SUPPL13Null0
SUPPL14Null0
SUPPL15Null0
SUPPL18Null0
SUPPL35Null6
SUPPL37Null7
SUPPL40Null6
SUPPL43Null7
SUPPL44Null6
SUPPL45Null6
SUPPL46Null6
SUPPL47Null0
SUPPL48Null15
SUPPL49Null6

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

TAKEDA PHARMS USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21073
            [companyName] => TAKEDA PHARMS USA
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2017\/021073s049lbl.pdf#page=35"]
            [products] => [{"drugName":"ACTOS","activeIngredients":"PIOGLITAZONE HYDROCHLORIDE","strength":"EQ 15MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"ACTOS","activeIngredients":"PIOGLITAZONE HYDROCHLORIDE","strength":"EQ 30MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"ACTOS","activeIngredients":"PIOGLITAZONE HYDROCHLORIDE","strength":"EQ 45MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/21\/2017","submission":"SUPPL-49","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021073s049lbl.pdf\"}]","notes":""},{"actionDate":"12\/12\/2016","submission":"SUPPL-48","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021073s048lbl.pdf\"}]","notes":""},{"actionDate":"11\/12\/2013","submission":"SUPPL-46","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021073s046lbl.pdf\"}]","notes":""},{"actionDate":"08\/04\/2011","submission":"SUPPL-44","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021073s043s044lbl.pdf\"}]","notes":""},{"actionDate":"08\/04\/2011","submission":"SUPPL-44","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021073s043s044lbl.pdf\"}]","notes":""},{"actionDate":"08\/04\/2011","submission":"SUPPL-43","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021073s043s044lbl.pdf\"}]","notes":""},{"actionDate":"02\/03\/2011","submission":"SUPPL-35","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021073s035lbl.pdf\"}]","notes":""},{"actionDate":"09\/09\/2009","submission":"SUPPL-37","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021073s037lbl.pdf\"}]","notes":""},{"actionDate":"09\/09\/2009","submission":"SUPPL-37","supplementCategories":"REMS-Proposal","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021073s037lbl.pdf\"}]","notes":""},{"actionDate":"12\/11\/2008","submission":"SUPPL-34","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021073s034lbl.pdf\"}]","notes":""},{"actionDate":"09\/06\/2007","submission":"SUPPL-30","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021073s030lbl.pdf\"}]","notes":""},{"actionDate":"08\/14\/2007","submission":"SUPPL-31","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021073s031lbl.pdf\"}]","notes":""},{"actionDate":"02\/25\/2007","submission":"SUPPL-26","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021073s026lbl.pdf\"}]","notes":""},{"actionDate":"11\/04\/2006","submission":"SUPPL-28","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-27","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021073s027lbl.pdf\"}]","notes":""},{"actionDate":"08\/03\/2004","submission":"SUPPL-23","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21073s023lbl.pdf\"}]","notes":""},{"actionDate":"07\/20\/2004","submission":"SUPPL-24","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21073s024lbl.pdf\"}]","notes":""},{"actionDate":"11\/26\/2003","submission":"SUPPL-20","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/21073se8-020_actos_lbl.pdf\"}]","notes":""},{"actionDate":"06\/11\/2003","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/21073slr071_actos_lbl.pdf\"}]","notes":""},{"actionDate":"07\/12\/2002","submission":"SUPPL-10","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21073s10lbl.pdf\"}]","notes":""},{"actionDate":"07\/15\/1999","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1999\\\/21073lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ACTOS","submission":"PIOGLITAZONE HYDROCHLORIDE","actionType":"EQ 15MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ACTOS","submission":"PIOGLITAZONE HYDROCHLORIDE","actionType":"EQ 30MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ACTOS","submission":"PIOGLITAZONE HYDROCHLORIDE","actionType":"EQ 45MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-12-21
        )

)
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