Skip to content
Application 211530
- Type
- NDA
- Sponsor
- HOSPIRA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BENDAMUSTINE | BENDAMUSTINE | SOLUTION;IV (INFUSION) | 25MG/ML | No | No |
| 002 | BENDAMUSTINE | BENDAMUSTINE | SOLUTION;IV (INFUSION) | 100MG/4ML | No | No |
| 003 | BENDAMUSTINE | BENDAMUSTINE | SOLUTION;IV (INFUSION) | 200MG/8ML | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 77318 | SUPPL | 2024-01-26 |
| 77309 | SUPPL | 2024-01-26 |
| 75996 | ORIG | 2023-10-31 |
| 72912 | ORIG | 2022-12-16 |
| 57574 | ORIG | 2019-02-13 |