Application 204230
- Type
- ANDA
- Sponsor
- APOTEX INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BENDAMUSTINE HYDROCHLORIDE | BENDAMUSTINE HYDROCHLORIDE | POWDER;INTRAVENOUS | 25MG/VIAL | No | No |
| 002 | BENDAMUSTINE HYDROCHLORIDE | BENDAMUSTINE HYDROCHLORIDE | POWDER; IV (INFUSION) | 100MG/VIAL | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 49694 | ORIG | 2017-09-07 |