Documents
Application Sponsors
| BLA 205692 | ELI LILLY AND CO | |
Marketing Status
Application Products
| 001 | SOLUTION;SUBCUTANEOUS | 300 UNITS/3ML (100 UNITS/ML) | 0 | BASAGLAR | INSULIN GLARGINE |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2015-12-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2016-06-17 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2016-06-01 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2018-09-05 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2019-11-15 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2019-11-15 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2019-11-15 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 33 | AP | 2021-07-20 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 40 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 5 | Null | 6 |
| SUPPL | 19 | Null | 6 |
| SUPPL | 21 | Null | 6 |
| SUPPL | 24 | Null | 7 |
| SUPPL | 25 | Null | 15 |
| SUPPL | 33 | Null | 15 |
CDER Filings
ELI LILLY AND CO
cder:Array
(
[0] => Array
(
[ApplNo] => 205692
[companyName] => ELI LILLY AND CO
[docInserts] => ["",""]
[products] => [{"drugName":"BASAGLAR","activeIngredients":"INSULIN GLARGINE","strength":"300 UNITS\/3ML (100 UNITS\/ML)","dosageForm":"SOLUTION;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"11\/15\/2019","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205692s021s024s025lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205692lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"12\/16\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205692lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/205692Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/205692Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"11\/15\/2019","submission":"SUPPL-25","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205692s021s024s025lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"11\/15\/2019","submission":"SUPPL-24","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/15\/2019","submission":"SUPPL-21","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/05\/2018","submission":"SUPPL-19","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/01\/2016","submission":"SUPPL-5","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/17\/2016","submission":"SUPPL-2","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/17\/2016","submission":"SUPPL-1","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-11-15
)
)