Application 212209
- Type
- NDA
- Sponsor
- SLAYBACK PHARMA LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BENDAMUSTINE HYDROCHLORIDE | BENDAMUSTINE HYDROCHLORIDE | INJECTABLE;INJECTION | 100 mg/m2 | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 71225-120 | VIVIMUSTA | BENDAMUSTINE HYDROCHLORIDE | Slayback Pharma LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 77643 | SUPPL | 2024-02-28 |
| 77640 | SUPPL | 2024-02-28 |
| 77442 | SUPPL | 2024-02-14 |
| 77478 | SUPPL | 2024-02-12 |
| 75500 | ORIG | 2023-09-18 |
| 74269 | SUPPL | 2023-05-16 |
| 72834 | ORIG | 2022-12-09 |
| 63803 | ORIG | 2020-07-06 |