Application 020563
- Type
- BLA
- Sponsor
- LILLY
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HUMALOG | INSULIN LISPRO RECOMBINANT | INJECTABLE;INJECTION | 100 UNITS/ML | No | No |
| 002 | HUMALOG PEN | INSULIN LISPRO RECOMBINANT | INJECTABLE;INJECTION | 100 UNITS/ML | No | No |
| 003 | HUMALOG KWIKPEN | INSULIN LISPRO RECOMBINANT | INJECTABLE;INJECTION | 100 UNITS/ML | No | No |
| 004 | HUMALOG KWIKPEN | INSULIN LISPRO RECOMBINANT | INJECTABLE;INJECTION | 200UNITS/ML | No | No |
| 005 | HUMALOG TEMPO PEN | INSULIN LISPRO RECOMBINANT | INJECTABLE;INJECTION | 100UNITS/ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0002-7510 | Humalog | Insulin lispro | Eli Lilly and Company | BLA | Current |
| 0002-7510 | Humalog | Insulin lispro | Eli Lilly and Company | BLA | Current |
| 0002-7510 | Humalog | Insulin lispro | Eli Lilly and Company | BLA | Current |
| 0002-7510 | Humalog | Insulin lispro | Eli Lilly and Company | NDA | Current |
| 0002-7510 | Humalog | Insulin lispro | Eli Lilly and Company | NDA | Current |
| 0002-7510 | Humalog | Insulin lispro | Eli Lilly and Company | NDA | Current |
| 0002-7510 | Humalog | Insulin lispro | Eli Lilly and Company | NDA | Current |
| 0002-7510 | Humalog | Insulin lispro | Eli Lilly and Company | NDA | Current |
| 0002-7510 | Humalog | Insulin lispro | Eli Lilly and Company | NDA | Current |
| 0002-7510 | Humalog | Insulin lispro | Eli Lilly and Company | BLA | Current |
| 0002-7516 | Humalog | Insulin lispro | Eli Lilly and Company | NDA | Current |
| 0002-7516 | Humalog | Insulin lispro | Eli Lilly and Company | NDA | Current |
| 0002-7516 | Humalog | Insulin lispro | Eli Lilly and Company | NDA | Current |
| 0002-7516 | Humalog | Insulin lispro | Eli Lilly and Company | NDA | Current |
| 0002-7516 | Humalog | Insulin lispro | Eli Lilly and Company | NDA | Current |
| 0002-7516 | Humalog | Insulin lispro | Eli Lilly and Company | NDA | Current |
| 0002-7516 | Humalog | Insulin lispro | Eli Lilly and Company | BLA | Current |
| 0002-7516 | Humalog | Insulin lispro | Eli Lilly and Company | BLA | Current |
| 0002-7516 | Humalog | Insulin lispro | Eli Lilly and Company | BLA | Current |
| 0002-7516 | Humalog | Insulin lispro | Eli Lilly and Company | BLA | Current |
| 0002-7714 | Humalog | Insulin lispro | Eli Lilly and Company | NDA | Current |
| 0002-7714 | Humalog | Insulin lispro | Eli Lilly and Company | NDA | Current |
| 0002-7714 | Humalog | Insulin lispro | Eli Lilly and Company | NDA | Current |
| 0002-7714 | Humalog | Insulin lispro | Eli Lilly and Company | NDA | Current |
| 0002-7714 | Humalog | Insulin lispro | Eli Lilly and Company | NDA | Current |
| 0002-7714 | Humalog | Insulin lispro | Eli Lilly and Company | NDA | Current |
| 0002-7714 | Humalog | Insulin lispro | Eli Lilly and Company | BLA | Current |
| 0002-7714 | Humalog | Insulin lispro | Eli Lilly and Company | BLA | Current |
| 0002-7714 | Humalog | Insulin lispro | Eli Lilly and Company | BLA | Current |
| 0002-7714 | Humalog | Insulin lispro | Eli Lilly and Company | BLA | Current |
| 0002-7737 | Insulin Lispro | Insulin lispro | Eli Lilly and Company | BLA | Current |
| 0002-7737 | Insulin Lispro | Insulin lispro | Eli Lilly and Company | BLA | Current |
| 0002-7737 | Insulin Lispro | Insulin lispro | Eli Lilly and Company | BLA | Current |
| 0002-7737 | Insulin Lispro | Insulin lispro | Eli Lilly and Company | NDA AUTHORIZED GENERIC | Current |
| 0002-7752 | Insulin Lispro | Insulin lispro | Eli Lilly and Company | BLA | Current |
| 0002-7752 | Insulin Lispro | Insulin lispro | Eli Lilly and Company | BLA | Current |
| 0002-7752 | Insulin Lispro | Insulin lispro | Eli Lilly and Company | BLA | Current |
| 0002-7752 | Insulin Lispro | Insulin lispro | Eli Lilly and Company | NDA AUTHORIZED GENERIC | Current |
| 0002-8213 | Humalog | Insulin lispro | Eli Lilly and Company | NDA | Current |
| 0002-8213 | Humalog | Insulin lispro | Eli Lilly and Company | NDA | Current |
| 0002-8213 | Humalog | Insulin lispro | Eli Lilly and Company | BLA | Current |
| 0002-8213 | Humalog | Insulin lispro | Eli Lilly and Company | BLA | Current |
| 0002-8213 | Humalog | Insulin lispro | Eli Lilly and Company | BLA | Current |
| 0002-8213 | Humalog | Insulin lispro | Eli Lilly and Company | BLA | Current |
| 0002-8222 | Insulin Lispro | Insulin lispro | Eli Lilly and Company | BLA | Current |
| 0002-8222 | Insulin Lispro | Insulin lispro | Eli Lilly and Company | BLA | Current |
| 0002-8222 | Insulin Lispro | Insulin lispro | Eli Lilly and Company | BLA | Current |
| 0002-8222 | Insulin Lispro | Insulin lispro | Eli Lilly and Company | NDA AUTHORIZED GENERIC | Current |
| 0002-8799 | Humalog | Insulin lispro | Eli Lilly and Company | NDA | Current |
| 0002-8799 | Humalog | Insulin lispro | Eli Lilly and Company | NDA | Current |
| 0002-8799 | Humalog | Insulin lispro | Eli Lilly and Company | NDA | Current |
| 0002-8799 | Humalog | Insulin lispro | Eli Lilly and Company | NDA | Current |
| 0002-8799 | Humalog | Insulin lispro | Eli Lilly and Company | NDA | Current |
| 0002-8799 | Humalog | Insulin lispro | Eli Lilly and Company | NDA | Current |
| 0002-8799 | Humalog | Insulin lispro | Eli Lilly and Company | BLA | Current |
| 0002-8799 | Humalog | Insulin lispro | Eli Lilly and Company | BLA | Current |
| 0002-8799 | Humalog | Insulin lispro | Eli Lilly and Company | BLA | Current |
| 0002-8799 | Humalog | Insulin lispro | Eli Lilly and Company | BLA | Current |
| 50090-1375 | Humalog | Insulin lispro | A-S Medication Solutions | BLA | Current |
| 50090-1375 | Humalog | Insulin lispro | A-S Medication Solutions | BLA | Current |
| 50090-1375 | Humalog | Insulin lispro | A-S Medication Solutions | NDA | Current |
| 50090-1663 | Humalog | Insulin lispro | A-S Medication Solutions | NDA | Current |
| 50090-1663 | Humalog | Insulin lispro | A-S Medication Solutions | NDA | Current |
| 50090-1663 | Humalog | Insulin lispro | A-S Medication Solutions | BLA | Current |
| 50090-4073 | Humalog | Insulin lispro | A-S Medication Solutions | BLA | Current |
| 50090-4073 | Humalog | Insulin lispro | A-S Medication Solutions | BLA | Current |
| 50090-4488 | Humalog | Insulin lispro | A-S Medication Solutions | BLA | Current |
| 50090-4488 | Humalog | Insulin lispro | A-S Medication Solutions | BLA | Current |
| 50090-4488 | Humalog | Insulin lispro | A-S Medication Solutions | NDA | Current |
| 50090-5391 | Insulin Lispro | Insulin lispro | A-S Medication Solutions | BLA | Current |
| 55045-3602 | Humalog | Insulin lispro | Dispensing Solutions, Inc. | NDA | Current |
| 66733-773 | Insulin lispro | Insulin Lispro | ImClone LLC | BLA | Current |
| 66733-773 | Insulin lispro | Insulin Lispro | ImClone LLC | NDA AUTHORIZED GENERIC | Current |
| 66733-773 | Insulin lispro | Insulin Lispro | ImClone LLC | NDA AUTHORIZED GENERIC | Current |
| 66733-822 | Insulin Lispro | Insulin lispro | ImClone LLC | NDA AUTHORIZED GENERIC | Current |
| 66733-822 | Insulin Lispro | Insulin lispro | ImClone LLC | NDA AUTHORIZED GENERIC | Current |
| 66733-822 | Insulin Lispro | Insulin lispro | ImClone LLC | BLA | Current |
| 70518-1388 | Humalog | Insulin lispro | REMEDYREPACK INC. | NDA | Current |
| 70518-1388 | Humalog | Insulin lispro | REMEDYREPACK INC. | BLA | Current |
| 70518-1388 | Humalog | Insulin lispro | REMEDYREPACK INC. | BLA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 82184 | SUPPL | 2025-05-14 |
| 82258 | SUPPL | 2025-05-07 |
| 74876 | SUPPL | 2024-05-28 |
| 74870 | SUPPL | 2023-07-24 |
| 66376 | APPL | 2020-03-23 |
| 60923 | SUPPL | 2020-03-23 |
| 60921 | SUPPL | 2020-03-23 |
| 60919 | SUPPL | 2020-03-23 |
| 60864 | SUPPL | 2020-03-23 |
| 60863 | SUPPL | 2020-03-23 |
| 60862 | SUPPL | 2020-03-23 |
| 59698 | SUPPL | 2020-03-23 |
| 59696 | SUPPL | 2020-03-23 |
| 57662 | ORIG | 2020-03-23 |
| 57206 | SUPPL | 2020-03-23 |
| 56840 | SUPPL | 2020-03-23 |
| 56715 | SUPPL | 2020-03-23 |
| 56293 | SUPPL | 2020-03-23 |
| 56247 | SUPPL | 2020-03-23 |
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