Application 021536
- Type
- BLA
- Sponsor
- NOVO NORDISK INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LEVEMIR | INSULIN DETEMIR RECOMBINANT | INJECTABLE;SUBCUTANEOUS | 1000 UNITS/10ML (100 UNITS/ML) | No | No |
| 002 | LEVEMIR FLEXPEN | INSULIN DETEMIR RECOMBINANT | INJECTABLE;SUBCUTANEOUS | 300 UNITS/3ML (100 UNITS/ML) | No | No |
| 003 | LEVEMIR INNOLET | INSULIN DETEMIR RECOMBINANT | INJECTABLE;SUBCUTANEOUS | 300 UNITS/3ML (100 UNITS/ML) | No | No |
| 004 | LEVEMIR PENFILL | INSULIN DETEMIR RECOMBINANT | INJECTABLE;SUBCUTANEOUS | 300 UNITS/3ML (100 UNITS/ML) | No | No |
| 005 | LEVEMIR FLEXTOUCH | INSULIN DETEMIR RECOMBINANT | INJECTABLE;SUBCUTANEOUS | 300 UNITS/3ML (100 UNITS/ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0169-3687 | Levemir | insulin detemir | Novo Nordisk | BLA | Current |
| 0169-3687 | Levemir | insulin detemir | Novo Nordisk | BLA | Current |
| 0169-3687 | Levemir | insulin detemir | Novo Nordisk | BLA | Current |
| 0169-3687 | Levemir | insulin detemir | Novo Nordisk | BLA | Current |
| 0169-3687 | Levemir | insulin detemir | Novo Nordisk | NDA | Current |
| 0169-3687 | Levemir | insulin detemir | Novo Nordisk | NDA | Current |
| 0169-3687 | Levemir | insulin detemir | Novo Nordisk | NDA | Current |
| 0169-3687 | Levemir | insulin detemir | Novo Nordisk | BLA | Current |
| 0169-6432 | Levemir | insulin detemir | Novo Nordisk | BLA | Current |
| 0169-6438 | Levemir | insulin detemir | Novo Nordisk | NDA | Current |
| 0169-6438 | Levemir | insulin detemir | Novo Nordisk | NDA | Current |
| 0169-6438 | Levemir | insulin detemir | Novo Nordisk | NDA | Current |
| 0169-6438 | Levemir | insulin detemir | Novo Nordisk | BLA | Current |
| 0169-6438 | Levemir | insulin detemir | Novo Nordisk | BLA | Current |
| 0169-6438 | Levemir | insulin detemir | Novo Nordisk | BLA | Current |
| 0169-6438 | Levemir | insulin detemir | Novo Nordisk | BLA | Current |
| 0169-6438 | Levemir | insulin detemir | Novo Nordisk | BLA | Current |
| 50090-1276 | Levemir | insulin detemir | A-S Medication Solutions | BLA | Current |
| 50090-1276 | Levemir | insulin detemir | A-S Medication Solutions | BLA | Current |
| 50090-1276 | Levemir | insulin detemir | A-S Medication Solutions | BLA | Current |
| 50090-1276 | Levemir | insulin detemir | A-S Medication Solutions | BLA | Current |
| 50090-1276 | Levemir | insulin detemir | A-S Medication Solutions | NDA | Current |
| 50090-1276 | Levemir | insulin detemir | A-S Medication Solutions | NDA | Current |
| 50090-1475 | Levemir | insulin detemir | A-S Medication Solutions | NDA | Current |
| 50090-1475 | Levemir | insulin detemir | A-S Medication Solutions | NDA | Current |
| 50090-1475 | Levemir | insulin detemir | A-S Medication Solutions | BLA | Current |
| 50090-1475 | Levemir | insulin detemir | A-S Medication Solutions | BLA | Current |
| 50090-1475 | Levemir | insulin detemir | A-S Medication Solutions | BLA | Current |
| 50090-4501 | Levemir | insulin detemir | A-S Medication Solutions | BLA | Current |
| 50090-4501 | Levemir | insulin detemir | A-S Medication Solutions | BLA | Current |
| 50090-4501 | Levemir | insulin detemir | A-S Medication Solutions | NDA | Current |
| 68258-8977 | Levemir | insulin detemir | Dispensing Solutions, Inc. | NDA | Current |
| 70518-1387 | Levemir | insulin detemir | REMEDYREPACK INC. | NDA | Current |
| 70518-1462 | Levemir | insulin detemir | REMEDYREPACK INC. | BLA | Current |
| 70518-1462 | Levemir | insulin detemir | REMEDYREPACK INC. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 72867 | SUPPL | 2022-12-12 |
| 72847 | SUPPL | 2022-12-09 |
| 72837 | SUPPL | 2022-12-09 |
| 71522 | SUPPL | 2022-07-06 |
| 71508 | SUPPL | 2022-07-05 |
| 62424 | APPL | 2020-04-01 |
| 61596 | SUPPL | 2020-03-23 |
| 61473 | SUPPL | 2020-03-23 |
| 60905 | SUPPL | 2020-03-23 |
| 60904 | SUPPL | 2020-03-23 |
| 60899 | SUPPL | 2020-03-23 |
| 60898 | SUPPL | 2020-03-23 |
| 57318 | SUPPL | 2020-03-23 |
| 57248 | SUPPL | 2020-03-23 |
| 57202 | SUPPL | 2020-03-23 |
| 57201 | SUPPL | 2020-03-23 |
| 37178 | SUPPL | 2020-03-23 |
| 37177 | SUPPL | 2020-03-23 |
| 37176 | SUPPL | 2020-03-23 |
| 28056 | SUPPL | 2020-03-23 |
| 28055 | SUPPL | 2020-03-23 |
| 28054 | SUPPL | 2020-03-23 |
| 28053 | SUPPL | 2020-03-23 |
| 28052 | SUPPL | 2020-03-23 |
| 28051 | SUPPL | 2020-03-23 |
| 28050 | SUPPL | 2020-03-23 |
| 28049 | SUPPL | 2020-03-23 |
| 21724 | SUPPL | 2020-03-23 |
| 21723 | SUPPL | 2020-03-23 |
| 21722 | ORIG | 2020-03-23 |
| 15722 | SUPPL | 2020-03-23 |
| 15721 | SUPPL | 2020-03-23 |
| 15720 | SUPPL | 2020-03-23 |
| 15719 | SUPPL | 2020-03-23 |
| 15718 | SUPPL | 2020-03-23 |
| 15717 | SUPPL | 2020-03-23 |
| 15716 | SUPPL | 2020-03-23 |
| 15715 | SUPPL | 2020-03-23 |
| 15714 | SUPPL | 2020-03-23 |
| 15713 | ORIG | 2020-03-23 |
| 5677 | SUPPL | 2020-03-23 |
| 5676 | SUPPL | 2020-03-23 |
| 5675 | SUPPL | 2020-03-23 |
| 5674 | SUPPL | 2020-03-23 |
| 5673 | SUPPL | 2020-03-23 |
| 5672 | SUPPL | 2020-03-23 |
| 5671 | SUPPL | 2020-03-23 |
| 5670 | SUPPL | 2020-03-23 |
| 5669 | ORIG | 2020-03-23 |