Application 206256
- Type
- NDA
- Sponsor
- ACROTECH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BELEODAQ | BELINOSTAT | POWDER;INTRAVENOUS | 500MG/VIAL | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68152-108 | Beleodaq | Belinostat | Spectrum Pharmaceuticals, Inc. | NDA | Current |
| 68152-108 | Beleodaq | Belinostat | Acrotech Biopharma LLC | NDA | Current |
| 68152-108 | Beleodaq | Belinostat | Spectrum Pharmaceuticals, Inc. | NDA | Current |
| 69605-002 | Beleodaq | Belinostat | CENEXI - BLA | NDA | Current |
| 72893-002 | Beleodaq | Belinostat | Acrotech Biopharma LLC | NDA | Current |
| 72893-002 | Beleodaq | Belinostat | Acrotech Biopharma LLC | NDA | Current |
| 72893-002 | Beleodaq | Belinostat | Acrotech Biopharma LLC | NDA | Current |
| 72893-002 | Beleodaq | Belinostat | Acrotech Biopharma LLC | NDA | Current |
| 72893-002 | Beleodaq | Belinostat | Acrotech Biopharma Inc | NDA | Current |
| 72893-002 | Beleodaq | Belinostat | Acrotech Biopharma LLC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 80257 | SUPPL | 2024-11-21 |
| 80248 | SUPPL | 2024-11-21 |
| 70799 | SUPPL | 2022-04-22 |
| 70798 | SUPPL | 2022-04-21 |
| 61546 | SUPPL | 2020-01-10 |
| 61539 | SUPPL | 2020-01-09 |
| 48035 | SUPPL | 2017-04-14 |
| 48003 | SUPPL | 2017-04-13 |
| 44939 | ORIG | 2014-08-05 |
| 23017 | ORIG | 2014-08-05 |
| 32787 | ORIG | 2014-07-03 |
| 40532 | ORIG | 2014-07-02 |