Application 208157
- Type
- BLA
- Sponsor
- BAXTER HLTHCARE CORP
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MYXREDLIN | INSULIN HUMAN | SOLUTION;INTRAVENOUS | 100 UNITS/100ML (1 UNIT/ML) | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0338-0126 | MYXREDLIN | insulin human | Baxter Healthcare Corporation | BLA | Current |
| 0338-0126 | MYXREDLIN | insulin human | Baxter Healthcare Corporation | BLA | Current |
| 0338-0126 | MYXREDLIN | insulin human | Baxter Healthcare Corporation | BLA | Current |
| 0338-0126 | MYXREDLIN | insulin human | Baxter Healthcare Corporation | BLA | Current |
| 0338-0126 | MYXREDLIN | insulin human | Baxter Healthcare Corporation | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 81519 | SUPPL | 2025-03-11 |
| 81509 | SUPPL | 2025-03-11 |
| 63422 | SUPPL | 2020-06-05 |
| 62458 | APPL | 2020-04-07 |
| 61584 | ORIG | 2020-03-23 |
| 59157 | ORIG | 2020-03-23 |
| 59144 | ORIG | 2020-03-23 |