Application 216233
- Type
- ANDA
- Sponsor
- SCINOPHARM TAIWAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CLOFARABINE | CLOFARABINE | SOLUTION;INTRAVENOUS | 20MG/20ML (1MG/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A216233-001 | CLOFARABINE | CLOFARABINE | 20MG/20ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2025-01-03 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A216233-001 | AP |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A216233-001 | CLOFARABINE | 20MG/20ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2025-01-03 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A216233-001 | CLOFARABINE | 20MG/20ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2025-01-03 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216233-001 | CLOFARABINE | 20MG/20ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2025-01-03 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216233-001 | CLOFARABINE | 20MG/20ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2025-01-03 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216233-001 | CLOFARABINE | 20MG/20ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2025-01-03 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216233-001 | CLOFARABINE | 20MG/20ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2025-01-03 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216233-001 | CLOFARABINE | 20MG/20ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2025-01-03 | 03ed91905a0d… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216233-001 | CLOFARABINE | 20MG/20ML (1MG/ML) | SOLUTION / INTRAVENOUS | AP | 2025-01-03 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A216233-001 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A216233-001 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216233-001 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A216233-001 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216233-001 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216233-001 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216233-001 | AP | 1 | 03ed91905a0d… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A216233-001 | AP | 1 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| Clofarabine | CLOFARABINE | Dr.Reddy's Laboratories Inc | 0da6764d-5fac-7e0f-ea3e-a5aee55a8b2d | 2024-02-27 | Warnings, Adverse reactions | Clofarabine CLOFARABINE |
| CLOFARABINE | CLOFARABINE | Fosun Pharma USA Inc. | e956b1e0-2829-4872-8c09-99462d60e922 | 2023-02-15 | Warnings, Adverse reactions | CLOFARABINE CLOFARABINE |
| Clofarabine | CLOFARABINE | Meitheal Pharmaceuticals Inc. | 54436453-882e-406b-87a3-049d150101c6 | 2022-12-12 | Warnings, Adverse reactions | Clofarabine CLOFARABINE |
| Clofarabine | CLOFARABINE | Gland Pharma Limited | b7d3a96e-0280-4f14-b921-795996f75950 | 2022-11-21 | Warnings, Adverse reactions | Clofarabine CLOFARABINE |
| CLOFARABINE | CLOFARABINE | Zydus Lifesciences Limited | 4d8d8e81-01ba-4493-b458-7f6375c5bbae | 2022-10-18 | CLOFARABINE CLOFARABINE | |
| CLOFARABINE | CLOFARABINE | Eugia US LLC | 18adf4af-63ed-41e6-ab59-87085ce3e5fb | 2022-10-10 | Warnings, Adverse reactions | CLOFARABINE CLOFARABINE |
| Clofarabine | CLOFARABINE | Amneal Pharmaceuticals LLC | 0a273a2d-a1ff-412a-925e-696648730dae | 2022-08-23 | Warnings, Adverse reactions | Clofarabine CLOFARABINE |
| CLOFARABINE | CLOFARABINE | Fresenius Kabi USA, LLC | fe6ff0f9-7610-4a69-9b75-da7ec4bb7744 | 2020-07-14 | Warnings, Adverse reactions | CLOFARABINE CLOFARABINE |