Application 761025
- Type
- BLA
- Sponsor
- BOEHRINGER INGELHEIM
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PRAXBIND | IDARUCIZUMAB | INJECTABLE;INJECTION | 2.5G/50ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0597-0197 | Praxbind | idarucizumab | Boehringer Ingelheim Pharmaceuticals, Inc. | BLA | Current |
| 0597-0197 | Praxbind | idarucizumab | Boehringer Ingelheim Pharmaceuticals, Inc. | BLA | Current |
| 0597-0197 | Praxbind | idarucizumab | Boehringer Ingelheim Pharmaceuticals, Inc. | BLA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 70168 | SUPPL | 2022-02-15 |
| 70161 | SUPPL | 2022-02-14 |
| 53689 | SUPPL | 2018-04-16 |
| 53660 | SUPPL | 2018-04-12 |
| 43551 | ORIG | 2015-11-13 |
| 10660 | ORIG | 2015-10-20 |
| 40638 | ORIG | 2015-10-16 |