NDA 022426

TAKEDA PHARMS USA

FDA Drug Application

Application #022426

Documents

• Letter: 2016-04-07
• Label: 2013-02-12
• Label: 2015-09-21
• Review: 2014-04-17
• Letter: 2013-02-12
• Letter: 2015-09-01
• Label: 2016-04-07
• Other: 2013-02-12
• Letter: 2016-12-13
• Letter: 2016-12-14
• Label: 2016-12-19
• Medication Guide: 2016-12-27
• Label: 2017-12-26
• Letter: 2017-12-27
• Letter: 2019-07-02
• Label: 2019-07-05
• Medication Guide: 2019-07-05
• Letter: 2022-03-14
• Label: 2022-03-15
• Medication Guide: 2022-03-15

Application Sponsors

NDA 022426

TAKEDA PHARMS USA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006

Application Products

001	TABLET;ORAL	EQ 25MG BASE;EQ 15MG BASE	1	OSENI	ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE
002	TABLET;ORAL	EQ 25MG BASE;EQ 30MG BASE	1	OSENI	ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE
003	TABLET;ORAL	EQ 25MG BASE;EQ 45MG BASE	1	OSENI	ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE
004	TABLET;ORAL	EQ 12.5MG BASE;EQ 15MG BASE	1	OSENI	ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE
005	TABLET;ORAL	EQ 12.5MG BASE;EQ 30MG BASE	1	OSENI	ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE
006	TABLET;ORAL	EQ 12.5MG BASE;EQ 45MG BASE	1	OSENI	ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	2013-01-25	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	2016-04-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2016-03-17	STANDARD
LABELING; Labeling	SUPPL	5	AP	2015-08-28	901 REQUIRED
EFFICACY; Efficacy	SUPPL	6	AP	2016-12-12	STANDARD
LABELING; Labeling	SUPPL	9	AP	2016-12-12	STANDARD
LABELING; Labeling	SUPPL	10	AP	2017-12-21	STANDARD
LABELING; Labeling	SUPPL	12	AP	2019-07-01	901 REQUIRED
LABELING; Labeling	SUPPL	14	AP	2022-03-11	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	3	Null	7
SUPPL	4	Null	0
SUPPL	5	Null	15
SUPPL	6	Null	15
SUPPL	9	Null	7
SUPPL	10	Null	15
SUPPL	12	Null	7
SUPPL	14	Null	7

CDER Filings

TAKEDA PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22426
            [companyName] => TAKEDA PHARMS USA
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/022426s012lbl.pdf#page=43"]
            [products] => [{"drugName":"OSENI","activeIngredients":"ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE","strength":"EQ 25MG BASE;EQ 15MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"OSENI","activeIngredients":"ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE","strength":"EQ 25MG BASE;EQ 30MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"OSENI","activeIngredients":"ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE","strength":"EQ 25MG BASE;EQ 45MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"OSENI","activeIngredients":"ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE","strength":"EQ 12.5MG BASE;EQ 15MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"OSENI","activeIngredients":"ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE","strength":"EQ 12.5MG BASE;EQ 30MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"OSENI","activeIngredients":"ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE","strength":"EQ 12.5MG BASE;EQ 45MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"07\/01\/2019","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022426s012lbl.pdf\"}]","notes":""},{"actionDate":"12\/21\/2017","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022426s010lbl.pdf\"}]","notes":""},{"actionDate":"12\/12\/2016","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022426s009lbl.pdf\"}]","notes":""},{"actionDate":"04\/05\/2016","submission":"SUPPL-3","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022426s003lbl.pdf\"}]","notes":""},{"actionDate":"08\/28\/2015","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022426s005lbl.pdf\"}]","notes":""},{"actionDate":"01\/25\/2013","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022426s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"OSENI","submission":"ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE","actionType":"EQ 25MG BASE;EQ 15MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"OSENI","submission":"ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE","actionType":"EQ 25MG BASE;EQ 30MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"OSENI","submission":"ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE","actionType":"EQ 25MG BASE;EQ 45MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"OSENI","submission":"ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE","actionType":"EQ 12.5MG BASE;EQ 15MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"OSENI","submission":"ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE","actionType":"EQ 12.5MG BASE;EQ 30MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"OSENI","submission":"ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE","actionType":"EQ 12.5MG BASE;EQ 45MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-07-01
        )

)