Application 019938
- Type
- BLA
- Sponsor
- NOVO NORDISK INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NOVOLIN R | INSULIN RECOMBINANT HUMAN | INJECTABLE;INJECTION | 100 UNITS/ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0169-1833 | Novolin | Human Insulin | Novo Nordisk | BLA | Current |
| 0169-1833 | Novolin | Human Insulin | Novo Nordisk | BLA | Current |
| 0169-1833 | Novolin | Human Insulin | Novo Nordisk | NDA | Current |
| 0169-1833 | Novolin | Human Insulin | Novo Nordisk | NDA | Current |
| 0169-1833 | Novolin | Human Insulin | Novo Nordisk | NDA | Current |
| 0169-3003 | Novolin | Human Insulin | Novo Nordisk | BLA | Current |
| 0169-3003 | Novolin | Human Insulin | Novo Nordisk | BLA | Current |
| 0169-3003 | Novolin | Human Insulin | Novo Nordisk | NDA | Current |
| 0169-3003 | Novolin | Human Insulin | Novo Nordisk | NDA | Current |
| 50090-0497 | Novolin | Human Insulin | A-S Medication Solutions | BLA | Current |
| 50090-0497 | Novolin | Human Insulin | A-S Medication Solutions | NDA | Current |
| 64725-1833 | Novolin | Human Insulin | TYA Pharmaceuticals | NDA | Current |
| 68071-1701 | Novolin | Human Insulin | NuCare Pharmaceuticals,Inc. | BLA | Current |
| 68071-1701 | Novolin | Human Insulin | NuCare Pharmaceuticals,Inc. | NDA | Current |
| 68071-1701 | Novolin | Human Insulin | NuCare Pharmaceuticals,Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 72724 | SUPPL | 2022-11-27 |
| 72695 | SUPPL | 2022-11-25 |
| 66371 | APPL | 2020-03-23 |
| 60935 | SUPPL | 2020-03-23 |
| 60930 | SUPPL | 2020-03-23 |
| 54433 | SUPPL | 2020-03-23 |
| 54419 | SUPPL | 2020-03-23 |
| 41098 | SUPPL | 2020-03-23 |
| 34108 | SUPPL | 2020-03-23 |
| 34107 | SUPPL | 2020-03-23 |
| 34106 | SUPPL | 2020-03-23 |
| 34105 | SUPPL | 2020-03-23 |
| 34104 | SUPPL | 2020-03-23 |
| 20426 | SUPPL | 2020-03-23 |
| 19855 | SUPPL | 2020-03-23 |
| 19854 | SUPPL | 2020-03-23 |
| 19853 | SUPPL | 2020-03-23 |
| 19852 | SUPPL | 2020-03-23 |
| 19851 | SUPPL | 2020-03-23 |
| 19850 | SUPPL | 2020-03-23 |
| 11861 | SUPPL | 2020-03-23 |
| 11860 | SUPPL | 2020-03-23 |
| 11859 | SUPPL | 2020-03-23 |
| 11858 | SUPPL | 2020-03-23 |
| 11857 | SUPPL | 2020-03-23 |
| 11856 | SUPPL | 2020-03-23 |
| 1824 | SUPPL | 2020-03-23 |
| 1823 | SUPPL | 2020-03-23 |
| 1822 | SUPPL | 2020-03-23 |
| 1821 | SUPPL | 2020-03-23 |
| 1820 | SUPPL | 2020-03-23 |
| 1819 | SUPPL | 2020-03-23 |
| 1818 | SUPPL | 2020-03-23 |