Application 018781
- Type
- BLA
- Sponsor
- LILLY
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HUMULIN N | INSULIN SUSP ISOPHANE RECOMBINANT HUMAN | INJECTABLE;INJECTION | 100 UNITS/ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0002-0800 | Sterile Diluent | diluent | Eli Lilly and Company | BLA | Current |
| 0002-0800 | Sterile Diluent | diluent | Eli Lilly and Company | NDA | Current |
| 0002-0800 | Sterile Diluent | diluent | Eli Lilly and Company | NDA | Current |
| 0002-0800 | Sterile Diluent | diluent | Eli Lilly and Company | NDA | Current |
| 0002-0800 | Sterile Diluent | diluent | Eli Lilly and Company | BLA | Current |
| 0002-0800 | Sterile Diluent | diluent | Eli Lilly and Company | BLA | Current |
| 0002-8315 | Humulin | Insulin human | Eli Lilly and Company | BLA | Current |
| 0002-8315 | Humulin | Insulin human | Eli Lilly and Company | BLA | Current |
| 0002-8315 | Humulin | Insulin human | Eli Lilly and Company | BLA | Current |
| 0002-8315 | Humulin | Insulin human | Eli Lilly and Company | NDA | Current |
| 0002-8315 | Humulin | Insulin human | Eli Lilly and Company | NDA | Current |
| 0002-8315 | Humulin | Insulin human | Eli Lilly and Company | NDA | Current |
| 0002-8805 | Humulin | Insulin human | Eli Lilly and Company | BLA | Current |
| 0002-8805 | Humulin | Insulin human | Eli Lilly and Company | BLA | Current |
| 0002-8805 | Humulin | Insulin human | Eli Lilly and Company | BLA | Current |
| 0002-8805 | Humulin | Insulin human | Eli Lilly and Company | NDA | Current |
| 0002-8805 | Humulin | Insulin human | Eli Lilly and Company | NDA | Current |
| 0002-8805 | Humulin | Insulin human | Eli Lilly and Company | NDA | Current |
| 50090-0352 | Humulin | Insulin human | A-S Medication Solutions | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 71483 | SUPPL | 2022-06-30 |
| 71459 | SUPPL | 2022-06-28 |
| 60932 | SUPPL | 2020-03-23 |
| 60931 | SUPPL | 2020-03-23 |
| 60897 | SUPPL | 2020-03-23 |
| 60896 | SUPPL | 2020-03-23 |
| 59837 | SUPPL | 2020-03-23 |
| 59823 | SUPPL | 2020-03-23 |
| 56446 | SUPPL | 2020-03-23 |
| 56380 | SUPPL | 2020-03-23 |
| 46788 | SUPPL | 2020-03-23 |
| 46732 | SUPPL | 2020-03-23 |
| 33606 | SUPPL | 2020-03-23 |
| 33605 | SUPPL | 2020-03-23 |
| 33604 | SUPPL | 2020-03-23 |
| 33603 | SUPPL | 2020-03-23 |
| 33602 | SUPPL | 2020-03-23 |
| 20159 | SUPPL | 2020-03-23 |
| 16054 | SUPPL | 2020-03-23 |
| 16053 | SUPPL | 2020-03-23 |
| 16052 | SUPPL | 2020-03-23 |
| 16051 | SUPPL | 2020-03-23 |
| 16050 | SUPPL | 2020-03-23 |
| 16049 | SUPPL | 2020-03-23 |
| 16048 | SUPPL | 2020-03-23 |
| 16047 | SUPPL | 2020-03-23 |
| 16046 | SUPPL | 2020-03-23 |
| 11341 | SUPPL | 2020-03-23 |
| 11340 | SUPPL | 2020-03-23 |
| 11339 | SUPPL | 2020-03-23 |
| 11338 | SUPPL | 2020-03-23 |
| 11337 | SUPPL | 2020-03-23 |
| 11336 | SUPPL | 2020-03-23 |
| 11335 | SUPPL | 2020-03-23 |
| 11334 | SUPPL | 2020-03-23 |
| 11333 | SUPPL | 2020-03-23 |
| 11332 | SUPPL | 2020-03-23 |
| 11331 | SUPPL | 2020-03-23 |
| 1090 | SUPPL | 2020-03-23 |
| 1089 | SUPPL | 2020-03-23 |
| 1088 | SUPPL | 2020-03-23 |
| 1087 | SUPPL | 2020-03-23 |
| 1086 | SUPPL | 2020-03-23 |
| 1085 | SUPPL | 2020-03-23 |
| 1084 | SUPPL | 2020-03-23 |
| 1083 | SUPPL | 2020-03-23 |
| 1082 | SUPPL | 2020-03-23 |
| 1081 | SUPPL | 2020-03-23 |
| 1080 | SUPPL | 2020-03-23 |
| 1079 | SUPPL | 2020-03-23 |
| 66372 | APPL | 2020-03-22 |