Skip to contentApplication 214120
- Type
- NDA
- Sponsor
- CELGENE CORP
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ONUREG | AZACITIDINE | TABLET;ORAL | 200MG | No | No |
| 002 | ONUREG | AZACITIDINE | TABLET; ORAL | 300MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 59572-730 | ONUREG | azacitidine | Celgene Corporation | NDA | Current |
| 59572-730 | ONUREG | azacitidine | Celgene Corporation | NDA | Current |
| 59572-730 | ONUREG | azacitidine | Celgene Corporation | NDA | Current |
| 59572-730 | ONUREG | azacitidine | Celgene Corporation | NDA | Current |
| 59572-730 | ONUREG | azacitidine | Celgene Corporation | NDA | Current |
| 59572-740 | ONUREG | azacitidine | Celgene Corporation | NDA | Current |
| 59572-740 | ONUREG | azacitidine | Celgene Corporation | NDA | Current |
| 59572-740 | ONUREG | azacitidine | Celgene Corporation | NDA | Current |
| 59572-740 | ONUREG | azacitidine | Celgene Corporation | NDA | Current |
| 59572-740 | ONUREG | azacitidine | Celgene Corporation | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85677 | SUPPL | 2026-04-14 |
| 85673 | SUPPL | 2026-04-10 |
| 69839 | SUPPL | 2022-01-11 |
| 69830 | SUPPL | 2022-01-11 |
| 66059 | ORIG | 2021-02-02 |
| 64474 | ORIG | 2020-09-02 |
| 64467 | ORIG | 2020-09-01 |