Application 022273
- Type
- NDA
- Sponsor
- SANOFI AVENTIS US
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OFORTA | FLUDARABINE PHOSPHATE | TABLET;ORAL | 10MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022273-001 | OFORTA | FLUDARABINE PHOSPHATE | 10MG | TABLET / ORAL | 2008-12-18 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | N022273-001 | OFORTA | 10MG | TABLET / ORAL | 2008-12-18 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N022273-001 | OFORTA | 10MG | TABLET / ORAL | 2008-12-18 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N022273-001 | OFORTA | 10MG | TABLET / ORAL | 2008-12-18 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N022273-001 | OFORTA | 10MG | TABLET / ORAL | 2008-12-18 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N022273-001 | 7148207 | 2022-12-20 | U-944 | Drug product | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N022273-001 | 7148207 | 2022-12-20 | U-944 | Drug product | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N022273-001 | 7148207 | 2022-12-20 | U-944 | Drug product | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N022273-001 | 7148207 | 2022-12-20 | U-944 | Drug product | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N022273-001 | 7148207 | 2022-12-20 | U-944 | Drug product | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N022273-001 | 7148207 | 2022-12-20 | U-944 | Drug product | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N022273-001 | 7148207 | 2022-12-20 | U-944 | Drug product | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N022273-001 | 7148207 | 2022-12-20 | U-944 | Drug product | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N022273-001 | 7148207 | 2022-12-20 | U-944 | Drug product | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N022273-001 | 7148207 | 2022-12-20 | U-944 | Drug product | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N022273-001 | 7148207 | 2022-12-20 | U-944 | Drug product | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N022273-001 | 7148207 | 2022-12-20 | U-944 | Drug product | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N022273-001 | 7148207 | 2022-12-20 | U-944 | Drug product | ea99ee380514… | |
| 2023-01-26 05:58 UTC | 2023-01 | N022273-001 | 7148207 | 2022-12-20 | U-944 | Drug product | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N022273-001 | 7148207 | 2022-12-20 | U-944 | Drug product | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N022273-001 | 7148207 | 2022-12-20 | U-944 | Drug product | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N022273-001 | 7148207 | 2022-12-20 | U-944 | Drug product | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N022273-001 | 7148207 | 2022-12-20 | U-944 | Drug product | 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 |
|---|---|---|---|---|---|---|
| Fludarabine | FLUDARABINE PHOSPHATE | Fresenius Kabi USA, LLC | cf5255cc-91fd-4132-973b-764dba142eae | 2024-10-14 | Boxed warning, Warnings, Adverse reactions | FLUDARABINE PHOSPHATE |
| Fludarabine Phosphate | FLUDARABINE PHOSPHATE | Areva Pharmaceuticals | 8039c2e3-ffe5-3997-e053-2991aa0ad9d0 | 2023-02-14 | Boxed warning, Warnings, Adverse reactions | FLUDARABINE PHOSPHATE |
| Fludarabine Phosphate | FLUDARABINE PHOSPHATE | Lannett Company, Inc. | 0170c0f4-d502-4f8f-bdbf-6439f3ed33fb | 2023-01-31 | Boxed warning, Warnings, Adverse reactions | FLUDARABINE PHOSPHATE |
| Fludarabine phosphate | FLUDARABINE PHOSPHATE | Actavis Pharma, Inc. | 3adca34b-4f65-4e21-8058-3c01fc7fc9bb | 2022-09-30 | Boxed warning, Warnings, Adverse reactions | FLUDARABINE PHOSPHATE |
| Fludarabine Phosphate | FLUDARABINE PHOSPHATE | Sagent Pharmaceuticals | 20e5acf0-90b7-45c8-be78-91eaf77c9ac0 | 2021-07-22 | Boxed warning, Warnings, Adverse reactions | FLUDARABINE PHOSPHATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.