Application 019717
- Type
- BLA
- Sponsor
- LILLY
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HUMULIN 70/30 | INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN | INJECTABLE;INJECTION | 30 UNITS/ML;70 UNITS/ML | No | No |
| 002 | HUMULIN 70/30 PEN | INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN | INJECTABLE;INJECTION | 30 UNITS/ML;70 UNITS/ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0002-8715 | Humulin | Insulin human | Eli Lilly and Company | BLA | Current |
| 0002-8715 | Humulin | Insulin human | Eli Lilly and Company | BLA | Current |
| 0002-8715 | Humulin | Insulin human | Eli Lilly and Company | BLA | Current |
| 0002-8715 | Humulin | Insulin human | Eli Lilly and Company | BLA | Current |
| 0002-8715 | Humulin | Insulin human | Eli Lilly and Company | NDA | Current |
| 0002-8715 | Humulin | Insulin human | Eli Lilly and Company | NDA | Current |
| 0002-8715 | Humulin | Insulin human | Eli Lilly and Company | NDA | Current |
| 0002-8803 | Humulin | Insulin human | Eli Lilly and Company | BLA | Current |
| 0002-8803 | Humulin | Insulin human | Eli Lilly and Company | BLA | Current |
| 0002-8803 | Humulin | Insulin human | Eli Lilly and Company | BLA | Current |
| 0002-8803 | Humulin | Insulin human | Eli Lilly and Company | BLA | Current |
| 0002-8803 | Humulin | Insulin human | Eli Lilly and Company | NDA | Current |
| 0002-8803 | Humulin | Insulin human | Eli Lilly and Company | NDA | Current |
| 0002-8803 | Humulin | Insulin human | Eli Lilly and Company | NDA | Current |
| 50090-0444 | Humulin | Insulin human | A-S Medication Solutions | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 71484 | SUPPL | 2022-06-30 |
| 71460 | SUPPL | 2022-06-28 |
| 66373 | APPL | 2020-03-23 |
| 60943 | SUPPL | 2020-03-23 |
| 60942 | SUPPL | 2020-03-23 |
| 60890 | SUPPL | 2020-03-23 |
| 60889 | SUPPL | 2020-03-23 |
| 59831 | SUPPL | 2020-03-23 |
| 59824 | SUPPL | 2020-03-23 |
| 56448 | SUPPL | 2020-03-23 |
| 56379 | SUPPL | 2020-03-23 |
| 46787 | SUPPL | 2020-03-23 |
| 46733 | SUPPL | 2020-03-23 |
| 33887 | SUPPL | 2020-03-23 |
| 33886 | SUPPL | 2020-03-23 |
| 33885 | SUPPL | 2020-03-23 |
| 33884 | SUPPL | 2020-03-23 |
| 33883 | SUPPL | 2020-03-23 |
| 33882 | SUPPL | 2020-03-23 |
| 33881 | SUPPL | 2020-03-23 |
| 33880 | SUPPL | 2020-03-23 |
| 19119 | SUPPL | 2020-03-23 |
| 19118 | SUPPL | 2020-03-23 |
| 19117 | SUPPL | 2020-03-23 |
| 19116 | SUPPL | 2020-03-23 |
| 19115 | SUPPL | 2020-03-23 |
| 19114 | SUPPL | 2020-03-23 |
| 11651 | SUPPL | 2020-03-23 |
| 11650 | SUPPL | 2020-03-23 |
| 11649 | SUPPL | 2020-03-23 |
| 11648 | SUPPL | 2020-03-23 |
| 11647 | SUPPL | 2020-03-23 |
| 11646 | SUPPL | 2020-03-23 |
| 1539 | SUPPL | 2020-03-23 |
| 1538 | SUPPL | 2020-03-23 |
| 1537 | SUPPL | 2020-03-23 |
| 1536 | SUPPL | 2020-03-23 |
| 1535 | SUPPL | 2020-03-23 |
| 1534 | SUPPL | 2020-03-23 |
| 1533 | SUPPL | 2020-03-23 |
| 1532 | SUPPL | 2020-03-23 |
| 1531 | SUPPL | 2020-03-23 |
| 1530 | SUPPL | 2020-03-23 |
| 1529 | SUPPL | 2020-03-23 |
| 1528 | SUPPL | 2020-03-23 |
| 1527 | SUPPL | 2020-03-23 |
| 1526 | SUPPL | 2020-03-23 |