Documents
Application Sponsors
| NDA 203414 | TAKEDA PHARMS USA | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | EQ 12.5MG BASE;500MG | 1 | KAZANO | ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE |
| 002 | TABLET;ORAL | EQ 12.5MG BASE;1GM | 1 | KAZANO | ALOGLIPTIN BENZOATE; METFORMIN 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 | 2014-08-21 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2015-08-28 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 7 | AP | 2017-02-15 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2016-12-12 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 9 | 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 | 40 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 8 | Null | 15 |
| SUPPL | 9 | Null | 6 |
| SUPPL | 12 | Null | 7 |
| SUPPL | 13 | Null | 15 |
CDER Filings
TAKEDA PHARMS USA
cder:Array
(
[0] => Array
(
[ApplNo] => 203414
[companyName] => TAKEDA PHARMS USA
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2017\/203414s007lbl.pdf#page=32"]
[products] => [{"drugName":"KAZANO","activeIngredients":"ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE","strength":"EQ 12.5MG BASE;500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"KAZANO","activeIngredients":"ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE","strength":"EQ 12.5MG BASE;1GM","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
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[supplements] => [{"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\\\/203414s012lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","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\\\/203414s008s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/203414Orig1s008,s009ltr.pdf\"}]","notes":">"},{"actionDate":"12\/12\/2016","submission":"SUPPL-8","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203414s008s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/203414Orig1s008,s009ltr.pdf\"}]","notes":">"},{"actionDate":"02\/15\/2017","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/203414s007lbl.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\\\/203414s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/022271Orig1s007,022426Orig1s005,203414Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"08\/21\/2014","submission":"SUPPL-4","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"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\\\/203414s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/022271Orig1s005,022426Orig1s003,203414Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"10\/17\/2013","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-07-01
)
)