Documents
Application Sponsors
| BLA 205747 | ELI LILLY AND CO | |
Marketing Status
Application Products
| 001 | SOLUTION;SUBCUTANEOUS | 200 UNITS/ML | 0 | HUMALOG KWIKPEN | INSULIN LISPRO RECOMBINANT |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2015-05-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2016-08-05 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2017-01-06 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2017-06-06 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2018-11-01 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2019-08-13 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2019-11-15 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2019-11-15 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 2019-11-15 | 901 REQUIRED |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 8 | Null | 6 |
| SUPPL | 10 | Null | 15 |
| SUPPL | 18 | Null | 15 |
| SUPPL | 21 | Null | 7 |
| SUPPL | 22 | Null | 4 |
| SUPPL | 25 | Null | 6 |
| SUPPL | 26 | Null | 6 |
CDER Filings
ELI LILLY AND CO
cder:Array
(
[0] => Array
(
[ApplNo] => 205747
[companyName] => ELI LILLY AND CO
[docInserts] => ["",""]
[products] => [{"drugName":"HUMALOG KWIKPEN","activeIngredients":"INSULIN LISPRO RECOMBINANT","strength":"200 UNITS\/ML","dosageForm":"SOLUTION;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"11\/15\/2019","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020563s196s198s199,205747s022s025s026lbl.pdf\"}]","notes":""},{"actionDate":"05\/26\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205747s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"05\/26\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205747s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/205747Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/205747Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"11\/15\/2019","submission":"SUPPL-26","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020563s196s198s199,205747s022s025s026lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"11\/15\/2019","submission":"SUPPL-25","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/15\/2019","submission":"SUPPL-22","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/13\/2019","submission":"SUPPL-21","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/01\/2018","submission":"SUPPL-18","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/06\/2017","submission":"SUPPL-10","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/06\/2017","submission":"SUPPL-8","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/05\/2016","submission":"SUPPL-6","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/25\/2015","submission":"SUPPL-1","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-11-15
)
)