Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | TABLET;ORAL | EQ 2.5MG BASE | 1 | ONGLYZA | SAXAGLIPTIN HYDROCHLORIDE |
| 002 | TABLET;ORAL | EQ 5MG BASE | 1 | ONGLYZA | SAXAGLIPTIN HYDROCHLORIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2009-07-31 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 2 | AP | 2011-02-18 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 4 | AP | 2011-12-16 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2011-11-15 | UNKNOWN |
| LABELING; Labeling | SUPPL | 9 | AP | 2012-03-13 | UNKNOWN |
| EFFICACY; Efficacy | SUPPL | 11 | AP | 2013-05-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2014-01-23 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 14 | AP | 2016-04-05 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2015-08-28 | 901 REQUIRED |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2015-11-25 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 18 | AP | 2017-02-27 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2017-01-18 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2019-07-01 | 901 REQUIRED |
Submissions Property Types
| ORIG | 1 | Null | 6 |
| SUPPL | 2 | Null | 6 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 9 | Null | 7 |
| SUPPL | 11 | Null | 7 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 6 |
| SUPPL | 16 | Null | 15 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 6 |
| SUPPL | 19 | Null | 6 |
| SUPPL | 23 | Null | 7 |
CDER Filings
ASTRAZENECA AB
cder:Array
(
[0] => Array
(
[ApplNo] => 22350
[companyName] => ASTRAZENECA AB
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/022350s023lbl.pdf#page=31"]
[products] => [{"drugName":"ONGLYZA","activeIngredients":"SAXAGLIPTIN HYDROCHLORIDE","strength":"EQ 2.5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"ONGLYZA","activeIngredients":"SAXAGLIPTIN HYDROCHLORIDE","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"07\/01\/2019","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022350s023lbl.pdf\"}]","notes":""},{"actionDate":"02\/27\/2017","submission":"SUPPL-18","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022350s018lbl.pdf\"}]","notes":""},{"actionDate":"01\/18\/2017","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022350s019lbl.pdf\"}]","notes":""},{"actionDate":"04\/05\/2016","submission":"SUPPL-14","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022350s014lbl.pdf\"}]","notes":""},{"actionDate":"08\/28\/2015","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022350s016lbl.pdf\"}]","notes":""},{"actionDate":"05\/24\/2013","submission":"SUPPL-11","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022350s011lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2011","submission":"SUPPL-4","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022350s004lbl.pdf\"}]","notes":""},{"actionDate":"11\/15\/2011","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022350s007lbl.pdf\"}]","notes":""},{"actionDate":"02\/18\/2011","submission":"SUPPL-2","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022350s001s002lbl.pdf\"}]","notes":""},{"actionDate":"02\/18\/2011","submission":"SUPPL-1","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022350s001s002lbl.pdf\"}]","notes":""},{"actionDate":"07\/31\/2009","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022350lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"ONGLYZA","submission":"SAXAGLIPTIN HYDROCHLORIDE","actionType":"EQ 2.5MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ONGLYZA","submission":"SAXAGLIPTIN HYDROCHLORIDE","actionType":"EQ 5MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2019-07-01
)
)