Application 050794
- Type
- NDA
- Sponsor
- CELGENE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VIDAZA | AZACITIDINE | POWDER;INTRAVENOUS, SUBCUTANEOUS | 100MG/VIAL | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N050794-001 | VIDAZA | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2004-05-19 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N050794-001 | AP |
Orange Book exclusivity#
| Application-product | Exclusivity code | Expiration |
|---|---|---|
| N050794-001 | ODE-399 | 2029-05-20 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N050794-001 | VIDAZA | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2004-05-19 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050794-001 | VIDAZA | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2004-05-19 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N050794-001 | VIDAZA | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2004-05-19 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050794-001 | VIDAZA | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2004-05-19 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050794-001 | VIDAZA | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2004-05-19 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050794-001 | VIDAZA | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2004-05-19 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050794-001 | VIDAZA | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2004-05-19 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050794-001 | VIDAZA | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2004-05-19 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050794-001 | VIDAZA | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2004-05-19 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N050794-001 | VIDAZA | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2004-05-19 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050794-001 | VIDAZA | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2004-05-19 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050794-001 | VIDAZA | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2004-05-19 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050794-001 | VIDAZA | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2004-05-19 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N050794-001 | VIDAZA | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2004-05-19 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050794-001 | VIDAZA | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2004-05-19 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N050794-001 | VIDAZA | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2004-05-19 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N050794-001 | VIDAZA | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2004-05-19 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N050794-001 | VIDAZA | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2004-05-19 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N050794-001 | VIDAZA | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2004-05-19 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N050794-001 | VIDAZA | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2004-05-19 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N050794-001 | VIDAZA | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2004-05-19 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N050794-001 | VIDAZA | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2004-05-19 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N050794-001 | VIDAZA | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2004-05-19 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N050794-001 | VIDAZA | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2004-05-19 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N050794-001 | VIDAZA | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2004-05-19 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N050794-001 | VIDAZA | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2004-05-19 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N050794-001 | VIDAZA | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2004-05-19 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N050794-001 | VIDAZA | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2004-05-19 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N050794-001 | VIDAZA | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2004-05-19 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N050794-001 | VIDAZA | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2004-05-19 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N050794-001 | VIDAZA | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2004-05-19 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N050794-001 | VIDAZA | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2004-05-19 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N050794-001 | VIDAZA | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2004-05-19 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N050794-001 | VIDAZA | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2004-05-19 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N050794-001 | VIDAZA | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2004-05-19 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N050794-001 | VIDAZA | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2004-05-19 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N050794-001 | VIDAZA | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2004-05-19 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N050794-001 | VIDAZA | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2004-05-19 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N050794-001 | VIDAZA | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2004-05-19 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N050794-001 | VIDAZA | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | RLD, RS | 2004-05-19 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N050794-001 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050794-001 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N050794-001 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050794-001 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050794-001 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050794-001 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050794-001 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050794-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050794-001 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N050794-001 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050794-001 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050794-001 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050794-001 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N050794-001 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050794-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N050794-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N050794-001 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N050794-001 | AP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N050794-001 | AP | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N050794-001 | AP | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N050794-001 | AP | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N050794-001 | AP | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N050794-001 | AP | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N050794-001 | AP | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N050794-001 | AP | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N050794-001 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N050794-001 | AP | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N050794-001 | AP | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N050794-001 | AP | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N050794-001 | AP | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N050794-001 | AP | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N050794-001 | AP | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N050794-001 | AP | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N050794-001 | AP | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N050794-001 | AP | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N050794-001 | AP | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N050794-001 | AP | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N050794-001 | AP | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N050794-001 | AP | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N050794-001 | AP | 1 | cb3db0bc1861… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N050794-001 | ODE-399 | 2029-05-20 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050794-001 | I-889 | 2025-05-20 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050794-001 | ODE-399 | 2029-05-20 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N050794-001 | I-889 | 2025-05-20 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N050794-001 | ODE-399 | 2029-05-20 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050794-001 | I-889 | 2025-05-20 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050794-001 | ODE-399 | 2029-05-20 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050794-001 | I-889 | 2025-05-20 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050794-001 | ODE-399 | 2029-05-20 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050794-001 | I-889 | 2025-05-20 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050794-001 | ODE-399 | 2029-05-20 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050794-001 | I-889 | 2025-05-20 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050794-001 | ODE-399 | 2029-05-20 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050794-001 | I-889 | 2025-05-20 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050794-001 | ODE-399 | 2029-05-20 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050794-001 | I-889 | 2025-05-20 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050794-001 | ODE-399 | 2029-05-20 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N050794-001 | I-889 | 2025-05-20 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N050794-001 | ODE-399 | 2029-05-20 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050794-001 | I-889 | 2025-05-20 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050794-001 | ODE-399 | 2029-05-20 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050794-001 | I-889 | 2025-05-20 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050794-001 | ODE-399 | 2029-05-20 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050794-001 | I-889 | 2025-05-20 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050794-001 | ODE-399 | 2029-05-20 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N050794-001 | I-889 | 2025-05-20 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N050794-001 | ODE-399 | 2029-05-20 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N050794-001 | I-889 | 2025-05-20 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N050794-001 | ODE-399 | 2029-05-20 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N050794-001 | I-889 | 2025-05-20 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | N050794-001 | ODE-399 | 2029-05-20 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N050794-001 | I-889 | 2025-05-20 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | N050794-001 | ODE-399 | 2029-05-20 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N050794-001 | I-889 | 2025-05-20 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N050794-001 | ODE-399 | 2029-05-20 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N050794-001 | I-889 | 2025-05-20 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N050794-001 | ODE-399 | 2029-05-20 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N050794-001 | I-889 | 2025-05-20 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N050794-001 | ODE-399 | 2029-05-20 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N050794-001 | I-889 | 2025-05-20 | 3f0d92c62455… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| VIDAZA | AZACITIDINE | Celgene Corporation | 3495a71a-cc04-4776-851f-f185956f32af | 2024-01-29 | Warnings, Adverse reactions | 050794 NDA050794 59572-102 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0781-3253 | Azacitidine | azacitidine | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 0781-3253 | Azacitidine | azacitidine | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 0781-3253 | Azacitidine | azacitidine | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 0781-3253 | Azacitidine | azacitidine | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 0781-9253 | Azacitidine | azacitidine | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 0781-9253 | Azacitidine | azacitidine | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 0781-9253 | Azacitidine | azacitidine | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
| 59572-102 | VIDAZA | azacitidine | Celgene Corporation | NDA | Current |
| 59572-102 | VIDAZA | azacitidine | Celgene Corporation | NDA | Current |
| 59572-102 | VIDAZA | azacitidine | Celgene Corporation | NDA | Current |
| 59572-102 | VIDAZA | azacitidine | Celgene Corporation | NDA | Current |
| 59572-102 | VIDAZA | azacitidine | Celgene Corporation | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 78960 | SUPPL | 2024-07-02 |
| 78956 | SUPPL | 2024-07-02 |
| 72175 | SUPPL | 2022-09-28 |
| 71126 | SUPPL | 2022-05-23 |
| 71115 | SUPPL | 2022-05-20 |
| 62204 | SUPPL | 2020-03-19 |
| 62189 | SUPPL | 2020-03-19 |
| 55071 | SUPPL | 2018-08-02 |
| 54973 | SUPPL | 2018-07-25 |
| 45199 | SUPPL | 2016-08-23 |
| 45198 | SUPPL | 2016-08-23 |
| 39349 | SUPPL | 2015-12-24 |
| 30571 | SUPPL | 2015-12-18 |
| 8304 | SUPPL | 2014-01-14 |
| 18267 | SUPPL | 2014-01-13 |
| 39348 | SUPPL | 2012-12-21 |
| 30570 | SUPPL | 2012-01-27 |
| 39347 | SUPPL | 2012-01-25 |
| 39346 | SUPPL | 2011-08-24 |
| 18266 | SUPPL | 2011-08-24 |
| 30569 | SUPPL | 2011-08-22 |
| 8303 | SUPPL | 2011-08-22 |
| 39345 | SUPPL | 2008-08-26 |
| 8302 | SUPPL | 2008-08-22 |
| 30568 | SUPPL | 2008-02-25 |
| 39344 | SUPPL | 2007-02-02 |
| 30567 | SUPPL | 2005-07-08 |
| 22243 | ORIG | 2004-08-05 |
| 30566 | ORIG | 2004-05-26 |
| 18265 | ORIG | 2004-05-19 |