Application 216078
- Type
- NDA
- Sponsor
- CELERITY PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BENDAMUSTINE HYDROCHLORIDE | BENDAMUSTINE HYDROCHLORIDE | SOLUTION;IV (INFUSION) | 100MG/4ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 10019-079 | BENDAMUSTINE HYDROCHLORIDE | bendamustine hydrochloride | Baxter Healthcare Corporation | NDA | Current |