Documents
Application Sponsors
| BLA 761109 | ELI LILLY AND CO | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | 100UNITS/ML(U-100) | 0 | LYUMJEV | INSULIN LISPRO-AABC |
| 002 | INJECTABLE;INJECTION | 200UNITS/ML(U-200) | 0 | LYUMJEV | INSULIN LISPRO-AABC |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2020-06-15 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 3 | AP | 2021-08-13 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 4 | AP | 2022-10-14 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 4 | Null | 6 |
CDER Filings
ELI LILLY AND CO
cder:Array
(
[0] => Array
(
[ApplNo] => 761109
[companyName] => ELI LILLY AND CO
[docInserts] => ["",""]
[products] => [{"drugName":"LYUMJEV","activeIngredients":"INSULIN LISPRO-AABC","strength":"100UNITS\/ML(U-100)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"LYUMJEV","activeIngredients":"INSULIN LISPRO-AABC","strength":"200UNITS\/ML(U-200)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"06\/15\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761109s000lbl_replacement.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"06\/15\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761109s000lbl_replacement.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761109Orig1s000ltr_replacement.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2020-06-15
)
)