Application 205476
- Type
- ANDA
- Sponsor
- INNOPHARMA LICENSING
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BENDAMUSTINE HYDROCHLORIDE | BENDAMUSTINE HYDROCHLORIDE | POWDER;IV (INFUSION) | 25MG/VIAL | No | No |
| 002 | BENDAMUSTINE HYDROCHLORIDE | BENDAMUSTINE HYDROCHLORIDE | POWDER;IV (INFUSION) | 100MG/VIAL | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 19650 | ORIG | 2016-04-11 |