Application 204949
- Type
- ANDA
- Sponsor
- MYLAN INSTITUTIONAL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AZACITIDINE | AZACITIDINE | POWDER;INTRAVENOUS, SUBCUTANEOUS | 100MG/VIAL | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A204949-001 | AZACITIDINE | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | 2016-04-28 |
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 | A204949-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | 2016-04-28 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204949-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | 2016-04-28 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204949-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | 2016-04-28 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204949-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | 2016-04-28 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204949-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | 2016-04-28 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204949-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | 2016-04-28 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204949-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | 2016-04-28 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204949-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | 2016-04-28 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204949-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | 2016-04-28 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A204949-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | 2016-04-28 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204949-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | 2016-04-28 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204949-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | 2016-04-28 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204949-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | 2016-04-28 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A204949-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | 2016-04-28 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A204949-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-04-28 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A204949-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-04-28 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A204949-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-04-28 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A204949-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-04-28 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A204949-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-04-28 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A204949-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-04-28 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A204949-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-04-28 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A204949-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-04-28 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A204949-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-04-28 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A204949-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-04-28 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A204949-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-04-28 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A204949-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-04-28 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A204949-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-04-28 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A204949-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | 2016-04-28 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A204949-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | 2016-04-28 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A204949-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | 2016-04-28 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A204949-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | 2016-04-28 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A204949-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | 2016-04-28 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A204949-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | 2016-04-28 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A204949-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | 2016-04-28 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A204949-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | 2016-04-28 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A204949-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | 2016-04-28 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A204949-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-04-28 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A204949-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-04-28 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A204949-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-04-28 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A204949-001 | AZACITIDINE | 100MG/VIAL | POWDER / INTRAVENOUS, SUBCUTANEOUS | AP | 2016-04-28 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A204949-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A204949-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A204949-001 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A204949-001 | AP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A204949-001 | AP | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A204949-001 | AP | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A204949-001 | AP | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A204949-001 | AP | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A204949-001 | AP | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A204949-001 | AP | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A204949-001 | AP | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A204949-001 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A204949-001 | AP | 1 | ea99ee380514… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A204949-001 | AP | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A204949-001 | AP | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A204949-001 | AP | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A204949-001 | AP | 1 | cb3db0bc1861… |
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 |
|---|---|---|---|---|---|---|
| ONUREG | AZACITIDINE | Celgene Corporation | 0e95e33f-8aba-4f19-b332-2416580d358b | 2026-06-12 | Warnings, Adverse reactions | AZACITIDINE |
| Azacitidine | AZACITIDINE | BluePoint Laboratories. | cd9db533-8a49-4d01-99e2-b2db8db1ed38 | 2026-03-26 | Warnings, Adverse reactions | Azacitidine AZACITIDINE |
| Azacitidine | AZACITIDINE | Apotex Corp | a6a5ca37-37e8-ab65-bc0b-9c0682ab52f7 | 2025-09-16 | Warnings, Adverse reactions | Azacitidine AZACITIDINE |
| Azacitidine | AZACITIDINE | Civica, Inc. | 2d15b3ec-ed08-48c6-a400-34e55974afad | 2025-08-25 | Warnings, Adverse reactions | Azacitidine AZACITIDINE |
| Azacitidine | AZACITIDINE | Somerset Therapeutics LLC | 3bc4f406-2ec7-7169-e063-6394a90a81d9 | 2025-08-07 | Warnings, Adverse reactions | Azacitidine AZACITIDINE |
| AZACITIDINE | AZACITIDINE | Armas Pharmaceuticals Inc. | 5c0a2d5f-8c34-4c04-8425-7543965cedd4 | 2025-08-05 | Warnings, Adverse reactions | AZACITIDINE AZACITIDINE |
| Azacitidine | AZACITIDINE | Meitheal Pharmaceuticals Inc. | 3b96b508-046b-49ae-aefe-6d39c89a1d0e | 2025-07-21 | Warnings, Adverse reactions | Azacitidine AZACITIDINE |
| Azacitidine | AZACITIDINE | Meitheal Pharmaceuticals Inc. | 97b0917a-03fa-4cc4-91cf-1bed57a988c9 | 2025-07-21 | Warnings, Adverse reactions | Azacitidine AZACITIDINE |
| Azacitidine | AZACITIDINE | Fresenius Kabi USA, LLC | 3b594aba-e798-4105-b801-0b0d970747c1 | 2025-06-18 | Warnings, Adverse reactions | Azacitidine AZACITIDINE |
| Azacitidine | AZACITIDINE | Reliance Life Sciences Private Limited | 5804d999-96eb-4fd1-b7d8-de7867c5f1d6 | 2025-05-29 | Warnings, Adverse reactions | Azacitidine AZACITIDINE |
| Azacitidine | AZACITIDINE | BluePoint Laboratories | 5f0f9ee3-a5b1-4a25-a34c-7f38c8433f4a | 2025-05-26 | Warnings, Adverse reactions | Azacitidine AZACITIDINE |
| Azacitidine | AZACITIDINE | Camber Pharmaceuticals, Inc. | f02c9bef-e47f-4b70-95f6-9341d87346ed | 2025-04-08 | Warnings, Adverse reactions | Azacitidine AZACITIDINE |
| AZACITIDINE | AZACITIDINE FOR | Pilnova Pharma Inc | 0095c67b-42f3-47e6-92db-f77843727bca | 2024-12-16 | Warnings, Adverse reactions | AZACITIDINE |
| Azacitidine | AZACITIDINE | Accord Healthcare Inc. | 70140e11-33f1-2240-e053-2991aa0a0480 | 2024-12-03 | Warnings, Adverse reactions | Azacitidine AZACITIDINE |
| Azacitidine | AZACITIDINE | Dr. Reddy's Laboratories Inc. | 060d56e7-1a24-87c1-7f40-149ecf424f7c | 2024-10-30 | Warnings, Adverse reactions | Azacitidine AZACITIDINE |
| Azacitidine | AZACITIDINE | Sandoz Inc | 7f89fcbd-d3f4-4112-8733-69baea41255e | 2024-10-24 | Warnings, Adverse reactions | Azacitidine AZACITIDINE |
| AZACITIDINE | AZACITIDINE | Amneal Pharmaceuticals LLC | 80a43736-0598-4e4b-85ba-e29daa290c8f | 2024-08-20 | Warnings, Adverse reactions | AZACITIDINE AZACITIDINE |
| Azacitidine | AZACITIDINE | Dr. Reddy's Laboratories Inc. | 71d8d758-86c9-b571-aed1-719654fd4b82 | 2024-07-31 | Warnings, Adverse reactions | Azacitidine AZACITIDINE |
| Azacitidine | AZACITIDINE | Dr. Reddy's Laboratories Inc. | 33397835-15a9-d89f-bd75-8b915f5c4dbf | 2024-07-31 | Warnings, Adverse reactions | Azacitidine AZACITIDINE |
| Azacitidine | AZACITIDINE | NorthStar RxLLC | 81366ec1-9689-4857-ded6-3d6342fe5132 | 2024-07-31 | Warnings, Adverse reactions | Azacitidine AZACITIDINE |