Application 208751
- Type
- BLA
- Sponsor
- NOVO
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FIASP | INSULIN ASPART | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | 1000 UNITS/10ML (100 UNITS/ML) | No | No |
| 002 | FIASP FLEXTOUCH | INSULIN ASPART | SOLUTION;SUBCUTANEOUS | 300 UNITS/3ML (100 UNITS/ML) | No | No |
| 003 | FIASP PENFILL | INSULIN ASPART | SOLUTION;SUBCUTANEOUS | 300 UNITS/3ML (100 UNITS/ML) | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0169-3201 | Fiasp | insulin aspart injection | Novo Nordisk | BLA | Current |
| 0169-3201 | Fiasp | insulin aspart injection | Novo Nordisk | NDA | Current |
| 0169-3201 | Fiasp | insulin aspart injection | Novo Nordisk | NDA | Current |
| 0169-3201 | Fiasp | insulin aspart injection | Novo Nordisk | NDA | Current |
| 0169-3201 | Fiasp | insulin aspart injection | Novo Nordisk | NDA | Current |
| 0169-3201 | Fiasp | insulin aspart injection | Novo Nordisk | NDA | Current |
| 0169-3201 | Fiasp | insulin aspart injection | Novo Nordisk | NDA | Current |
| 0169-3201 | Fiasp | insulin aspart injection | Novo Nordisk | BLA | Current |
| 0169-3201 | Fiasp | insulin aspart injection | Novo Nordisk | BLA | Current |
| 0169-3201 | Fiasp | insulin aspart injection | Novo Nordisk | BLA | Current |
| 0169-3204 | Fiasp | insulin aspart injection | Novo Nordisk | BLA | Current |
| 0169-3204 | Fiasp | insulin aspart injection | Novo Nordisk | NDA | Current |
| 0169-3204 | Fiasp | insulin aspart injection | Novo Nordisk | NDA | Current |
| 0169-3204 | Fiasp | insulin aspart injection | Novo Nordisk | NDA | Current |
| 0169-3204 | Fiasp | insulin aspart injection | Novo Nordisk | NDA | Current |
| 0169-3204 | Fiasp | insulin aspart injection | Novo Nordisk | NDA | Current |
| 0169-3204 | Fiasp | insulin aspart injection | Novo Nordisk | NDA | Current |
| 0169-3204 | Fiasp | insulin aspart injection | Novo Nordisk | BLA | Current |
| 0169-3204 | Fiasp | insulin aspart injection | Novo Nordisk | BLA | Current |
| 0169-3204 | Fiasp | insulin aspart injection | Novo Nordisk | BLA | Current |
| 0169-3205 | Fiasp | insulin aspart injection | Novo Nordisk | NDA | Current |
| 0169-3205 | Fiasp | insulin aspart injection | Novo Nordisk | NDA | Current |
| 0169-3205 | Fiasp | insulin aspart injection | Novo Nordisk | NDA | Current |
| 0169-3205 | Fiasp | insulin aspart injection | Novo Nordisk | NDA | Current |
| 0169-3205 | Fiasp | insulin aspart injection | Novo Nordisk | NDA | Current |
| 0169-3205 | Fiasp | insulin aspart injection | Novo Nordisk | NDA | Current |
| 0169-3205 | Fiasp | insulin aspart injection | Novo Nordisk | BLA | Current |
| 0169-3205 | Fiasp | insulin aspart injection | Novo Nordisk | BLA | Current |
| 0169-3205 | Fiasp | insulin aspart injection | Novo Nordisk | BLA | Current |
| 0169-3205 | Fiasp | insulin aspart injection | Novo Nordisk | BLA | Current |
Documents
| Document | Submission type | Date |
|---|---|---|
| 74609 | SUPPL | 2023-06-22 |
| 74583 | SUPPL | 2023-06-22 |
| 62398 | APPL | 2020-03-31 |
| 61422 | SUPPL | 2020-03-23 |
| 61421 | SUPPL | 2020-03-23 |
| 61399 | SUPPL | 2020-03-23 |
| 61398 | SUPPL | 2020-03-23 |
| 60952 | SUPPL | 2020-03-23 |
| 60861 | SUPPL | 2020-03-23 |
| 60641 | SUPPL | 2020-03-23 |
| 60640 | SUPPL | 2020-03-23 |
| 60629 | SUPPL | 2020-03-23 |
| 60628 | SUPPL | 2020-03-23 |
| 55747 | SUPPL | 2020-03-23 |
| 55455 | SUPPL | 2020-03-23 |
| 55380 | SUPPL | 2020-03-23 |
| 53875 | ORIG | 2020-03-23 |
| 53008 | SUPPL | 2020-03-23 |
| 52858 | SUPPL | 2020-03-23 |
| 49906 | ORIG | 2020-03-23 |
| 49903 | ORIG | 2020-03-23 |
| 63070 | SUPPL | 1900-01-01 |
| 63069 | SUPPL | 1900-01-01 |
| 63068 | SUPPL | 1900-01-01 |
| 63067 | SUPPL | 1900-01-01 |