Application 205004
- Type
- NDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BORTEZOMIB | BORTEZOMIB | POWDER;INTRAVENOUS | 3.5MG/VIAL | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 63323-721 | Bortezomib | Bortezomib | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-721 | Bortezomib | Bortezomib | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-721 | Bortezomib | Bortezomib | Fresenius Kabi USA, LLC | NDA | Current |
| 63323-721 | Bortezomib | Bortezomib | Fresenius Kabi USA, LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 68720 | SUPPL | 2021-09-22 |
| 68685 | SUPPL | 2021-09-21 |
| 57403 | SUPPL | 2019-02-01 |
| 54895 | SUPPL | 2018-07-16 |
| 54877 | SUPPL | 2018-07-13 |
| 50696 | ORIG | 2017-12-14 |
| 50454 | ORIG | 2017-11-17 |
| 50320 | ORIG | 2017-11-07 |