Application 021810
- Type
- BLA
- Sponsor
- NOVO NORDISK INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NOVOLOG MIX 50/50 | INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT | INJECTABLE;SUBCUTANEOUS | 50 UNITS/ML;50 UNITS/ML | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 62399 | APPL | 2020-03-31 |
| 60917 | SUPPL | 2020-03-23 |
| 60916 | SUPPL | 2020-03-23 |
| 60873 | SUPPL | 2020-03-23 |
| 60872 | SUPPL | 2020-03-23 |
| 59663 | SUPPL | 2020-03-23 |
| 59642 | SUPPL | 2020-03-23 |
| 57611 | SUPPL | 2020-03-23 |
| 57505 | SUPPL | 2020-03-23 |
| 50470 | SUPPL | 2020-03-23 |
| 44650 | ORIG | 2020-03-23 |
| 42318 | ORIG | 2020-03-23 |
| 37686 | SUPPL | 2020-03-23 |
| 16408 | SUPPL | 2020-03-23 |
| 16407 | ORIG | 2020-03-23 |
| 6233 | SUPPL | 2020-03-23 |
| 6232 | SUPPL | 2020-03-23 |
| 6231 | ORIG | 2020-03-23 |