NDA 022024

TAKEDA PHARMS USA

FDA Drug Application

Application #022024

Documents

• Letter: 2009-05-14
• Letter: 2013-11-14
• Letter: 2010-12-28
• Letter: 2011-08-04
• Letter: 2012-05-22
• Label: 2013-11-14
• Label: 2010-12-26
• Label: 2011-08-04
• Review: 2010-03-25
• Other Important Information from FDA: 2009-11-12
• Letter: 2011-08-04
• Label: 2009-07-08
• Label: 2011-08-04
• Letter: 2016-12-13
• Letter: 2016-12-14
• Label: 2016-12-15
• Label: 2017-12-26
• Medication Guide: 2017-12-26
• Letter: 2017-12-27

Application Sponsors

NDA 022024

TAKEDA PHARMS USA

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	1GM;EQ 15MG BASE	1	ACTOPLUS MET XR	METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
002	TABLET, EXTENDED RELEASE;ORAL	1GM;EQ 30MG BASE	1	ACTOPLUS MET XR	METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2009-05-12	STANDARD
LABELING; Labeling	SUPPL	2	AP	2010-12-22	UNKNOWN
LABELING; Labeling	SUPPL	7	AP	2011-08-04	901 REQUIRED
REMS; REMS	SUPPL	8	AP	2011-08-04	N/A
REMS; REMS	SUPPL	9	AP	2012-05-17	N/A
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2013-09-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2015-03-16	STANDARD
EFFICACY; Efficacy	SUPPL	12	AP	2016-12-12	STANDARD
LABELING; Labeling	SUPPL	13	AP	2016-12-12	901 REQUIRED
LABELING; Labeling	SUPPL	14	AP	2017-12-21	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	2	Null	6
SUPPL	7	Null	6
SUPPL	8	Null	6
SUPPL	9	Null	6
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	15
SUPPL	13	Null	6
SUPPL	14	Null	6

CDER Filings

TAKEDA PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22024
            [companyName] => TAKEDA PHARMS USA
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2017\/022024s014lbl.pdf#page=41"]
            [products] => [{"drugName":"ACTOPLUS MET XR","activeIngredients":"METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE","strength":"1GM;EQ 15MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"ACTOPLUS MET XR","activeIngredients":"METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE","strength":"1GM;EQ 30MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"12\/21\/2017","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022024s014lbl.pdf\"}]","notes":""},{"actionDate":"12\/12\/2016","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022024s013lbl.pdf\"}]","notes":""},{"actionDate":"11\/12\/2013","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022024s001lbl.pdf\"}]","notes":""},{"actionDate":"08\/04\/2011","submission":"SUPPL-8","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022024s007s008lbl.pdf\"}]","notes":""},{"actionDate":"08\/04\/2011","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022024s007s008lbl.pdf\"}]","notes":""},{"actionDate":"08\/04\/2011","submission":"SUPPL-7","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022024s007s008lbl.pdf\"}]","notes":""},{"actionDate":"12\/22\/2010","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022024s002lbl.pdf\"}]","notes":""},{"actionDate":"12\/22\/2010","submission":"SUPPL-2","supplementCategories":"REMS-Proposal","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022024s002lbl.pdf\"}]","notes":""},{"actionDate":"05\/12\/2009","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022024s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ACTOPLUS MET XR","submission":"METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE","actionType":"1GM;EQ 15MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"ACTOPLUS MET XR","submission":"METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE","actionType":"1GM;EQ 30MG BASE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-12-21
        )

)