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Application 761109
- Type
- BLA
- Sponsor
- ELI LILLY AND CO
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LYUMJEV | INSULIN LISPRO-AABC | INJECTABLE;INJECTION | 100UNITS/ML(U-100) | No | No |
| 002 | LYUMJEV | INSULIN LISPRO-AABC | INJECTABLE;INJECTION | 200UNITS/ML(U-200) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0002-7726 | LYUMJEV | Insulin lispro-aabc | Eli Lilly and Company | BLA | Current |
| 0002-7726 | LYUMJEV | Insulin lispro-aabc | Eli Lilly and Company | BLA | Current |
| 0002-7726 | LYUMJEV | Insulin lispro-aabc | Eli Lilly and Company | BLA | Current |
| 0002-7726 | LYUMJEV | Insulin lispro-aabc | Eli Lilly and Company | BLA | Current |
| 0002-7728 | LYUMJEV | Insulin lispro-aabc | Eli Lilly and Company | BLA | Current |
| 0002-7728 | LYUMJEV | Insulin lispro-aabc | Eli Lilly and Company | BLA | Current |
| 0002-7728 | LYUMJEV | Insulin lispro-aabc | Eli Lilly and Company | BLA | Current |
| 0002-7728 | LYUMJEV | Insulin lispro-aabc | Eli Lilly and Company | BLA | Current |
| 0002-8207 | LYUMJEV | Insulin lispro-aabc | Eli Lilly and Company | BLA | Current |
| 0002-8207 | LYUMJEV | Insulin lispro-aabc | Eli Lilly and Company | BLA | Current |
| 0002-8207 | LYUMJEV | Insulin lispro-aabc | Eli Lilly and Company | BLA | Current |
| 0002-8207 | LYUMJEV | Insulin lispro-aabc | Eli Lilly and Company | BLA | Current |
| 0002-8228 | LYUMJEV | Insulin lispro-aabc | Eli Lilly and Company | BLA | Current |
| 0002-8228 | LYUMJEV | Insulin lispro-aabc | Eli Lilly and Company | BLA | Current |
| 0002-8228 | LYUMJEV | Insulin lispro-aabc | Eli Lilly and Company | BLA | Current |
| 0002-8228 | LYUMJEV | Insulin lispro-aabc | Eli Lilly and Company | BLA | Current |
| 0002-8235 | LYUMJEV | Insulin lispro-aabc | Eli Lilly and Company | BLA | Current |
| 0002-8235 | LYUMJEV | Insulin lispro-aabc | Eli Lilly and Company | BLA | Current |
| 0002-8235 | LYUMJEV | Insulin lispro-aabc | Eli Lilly and Company | BLA | Current |
| 0002-8235 | LYUMJEV | Insulin lispro-aabc | Eli Lilly and Company | BLA | Current |
| 0002-8351 | LYUMJEV | Insulin lispro-aabc | Eli Lilly and Company | BLA | Current |
| 0002-8351 | LYUMJEV | Insulin lispro-aabc | Eli Lilly and Company | BLA | Current |
| 0002-8351 | LYUMJEV | Insulin lispro-aabc | Eli Lilly and Company | BLA | Current |
| 0002-8351 | LYUMJEV | Insulin lispro-aabc | Eli Lilly and Company | BLA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 72394 | SUPPL | 2022-10-17 |
| 72344 | SUPPL | 2022-10-17 |
| 68391 | SUPPL | 2021-08-17 |
| 68376 | SUPPL | 2021-08-16 |
| 67534 | ORIG | 2021-05-18 |
| 66000 | ORIG | 2021-01-26 |
| 65976 | ORIG | 2021-01-25 |
| 63603 | ORIG | 2020-06-17 |
| 63571 | ORIG | 2020-06-15 |