Documents
Application Sponsors
| NDA 022271 | TAKEDA PHARMS USA | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET;ORAL | EQ 6.25MG BASE | 1 | NESINA | ALOGLIPTIN BENZOATE |
| 002 | TABLET;ORAL | EQ 12.5MG BASE | 1 | NESINA | ALOGLIPTIN BENZOATE |
| 003 | TABLET;ORAL | EQ 25MG BASE | 1 | NESINA | ALOGLIPTIN BENZOATE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2013-01-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2013-06-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2013-08-15 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 5 | AP | 2016-04-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2015-07-20 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2015-08-28 | 901 REQUIRED |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2016-04-19 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2016-05-27 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2016-12-12 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2019-07-01 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 13 | AP | 2022-03-11 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 6 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 15 |
| SUPPL | 11 | Null | 31 |
| SUPPL | 12 | Null | 15 |
| SUPPL | 13 | Null | 6 |
CDER Filings
TAKEDA PHARMS USA
cder:Array
(
[0] => Array
(
[ApplNo] => 22271
[companyName] => TAKEDA PHARMS USA
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/022271s012lbl.pdf#page=29"]
[products] => [{"drugName":"NESINA","activeIngredients":"ALOGLIPTIN BENZOATE","strength":"EQ 6.25MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"NESINA","activeIngredients":"ALOGLIPTIN BENZOATE","strength":"EQ 12.5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"NESINA","activeIngredients":"ALOGLIPTIN BENZOATE","strength":"EQ 25MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[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\\\/022271s012lbl.pdf\"}]","notes":""},{"actionDate":"12\/12\/2016","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022271s011lbl.pdf\"}]","notes":""},{"actionDate":"05\/27\/2016","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022271s009lbl.pdf\"}]","notes":""},{"actionDate":"04\/05\/2016","submission":"SUPPL-5","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022271s005lbl.pdf\"}]","notes":""},{"actionDate":"08\/28\/2015","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022271s007lbl.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\\\/022271s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"NESINA","submission":"ALOGLIPTIN BENZOATE","actionType":"EQ 6.25MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"NESINA","submission":"ALOGLIPTIN BENZOATE","actionType":"EQ 12.5MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"NESINA","submission":"ALOGLIPTIN BENZOATE","actionType":"EQ 25MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-07-01
)
)