Application 215331
- Type
- NDA
- Sponsor
- MAIA PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BORTEZOMIB | BORTEZOMIB | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 3.5MG/3.5ML/VIAL | No | No |
| 002 | BORTEZOMIB | BORTEZOMIB | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 3.5MG/1.4ML/VIAL | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 70511-161 | Bortezomib | bortezomib | MAIA Pharmaceuticals, Inc. | NDA | Current |
| 70511-162 | Bortezomib | bortezomib | MAIA Pharmaceuticals, Inc. | NDA | Current |
| 72266-243 | Bortezomib | bortezomib | FOSUN PHARMA USA INC | NDA | Current |
| 72266-244 | Bortezomib | bortezomib | FOSUN PHARMA USA INC | NDA | Current |