Documents
Application Sponsors
| BLA 208673 | SANOFI-AVENTIS US | |
Marketing Status
Application Products
| 001 | SOLUTION;SUBCUTANEOUS | 300 UNITS/3ML;99MCG/3ML (100 UNITS/ML;33MCG/ML) | 0 | SOLIQUA 100/33 | INSULIN GLARGINE; LIXISENATIDE |
FDA Submissions
| TYPE 4; Type 4 - New Combination | ORIG | 1 | AP | 2016-11-21 | PRIORITY |
| LABELING; Labeling | SUPPL | 2 | AP | 2017-08-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2017-09-28 | N/A |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 2019-02-27 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2019-11-15 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2019-11-15 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 11 | AP | 2021-07-28 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2022-06-10 | 901 REQUIRED |
Submissions Property Types
| ORIG | 1 | Null | 6 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 8 | Null | 31 |
| SUPPL | 9 | Null | 6 |
| SUPPL | 11 | Null | 15 |
| SUPPL | 12 | Null | 6 |
CDER Filings
SANOFI-AVENTIS US
cder:Array
(
[0] => Array
(
[ApplNo] => 208673
[companyName] => SANOFI-AVENTIS US
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/208673s008s009lbl.pdf#page=30"]
[products] => [{"drugName":"SOLIQUA 100\/33","activeIngredients":"INSULIN GLARGINE; LIXISENATIDE","strength":"300 UNITS\/3ML;99MCG\/3ML (100 UNITS\/ML;33MCG\/ML)","dosageForm":"SOLUTION;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"11\/15\/2019","submission":"SUPPL-9","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208673s008s009lbl.pdf\"}]","notes":""},{"actionDate":"11\/15\/2019","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208673s008s009lbl.pdf\"}]","notes":""},{"actionDate":"11\/21\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208673s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"11\/21\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208673s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/208673Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/208673Orig1_toc.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"11\/15\/2019","submission":"SUPPL-9","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208673s008s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"11\/15\/2019","submission":"SUPPL-8","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/27\/2019","submission":"SUPPL-7","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/28\/2017","submission":"SUPPL-3","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/29\/2017","submission":"SUPPL-2","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-11-15
)
)