Application 208216
- Type
- NDA
- Sponsor
- ACTAVIS LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AZACITIDINE | AZACITIDINE | POWDER;INTRAVENOUS, SUBCUTANEOUS | 100MG/VIAL | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0591-2897 | Azacitidine | Azacitidine | Actavis Pharma, Inc. | NDA | Current |
| 68001-313 | Azacitidine | Azacitidine | BluePoint Laboratories | NDA | Current |
| 68001-313 | Azacitidine | Azacitidine | BluePoint Laboratories | NDA | Current |
| 68001-313 | Azacitidine | Azacitidine | BluePoint Laboratories | NDA | Current |
| 68001-313 | Azacitidine | Azacitidine | BluePoint Laboratories | NDA | Current |
| 68001-313 | Azacitidine | Azacitidine | BluePoint Laboratories | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 80681 | SUPPL | 2024-12-23 |
| 80660 | SUPPL | 2024-12-20 |
| 74471 | SUPPL | 2023-06-09 |
| 74465 | SUPPL | 2023-06-09 |
| 63952 | SUPPL | 2020-07-17 |
| 63892 | SUPPL | 2020-07-14 |
| 56091 | SUPPL | 2018-10-24 |
| 56086 | SUPPL | 2018-10-23 |
| 51031 | SUPPL | 2018-01-11 |
| 51027 | SUPPL | 2018-01-11 |
| 49024 | ORIG | 2017-07-20 |
| 10650 | ORIG | 2016-05-04 |
| 40626 | ORIG | 2016-05-03 |