Application 210852
- Type
- NDA
- Sponsor
- AVYXA HOLDINGS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FRINDOVYX | CYCLOPHOSPHAMIDE | SOLUTION;INTRAVENOUS | 500MG/ML (500MG/ML) | Yes | Yes |
| 002 | FRINDOVYX | CYCLOPHOSPHAMIDE | SOLUTION;INTRAVENOUS | 1GM/2ML (500MG/ML) | Yes | Yes |
| 003 | FRINDOVYX | CYCLOPHOSPHAMIDE | SOLUTION;INTRAVENOUS | 2GM/4ML (500MG/ML) | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N210852-001 | FRINDOVYX | CYCLOPHOSPHAMIDE | 500MG/ML (500MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-07 | |
| N210852-002 | FRINDOVYX | CYCLOPHOSPHAMIDE | 1GM/2ML (500MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-07 | |
| N210852-003 | FRINDOVYX | CYCLOPHOSPHAMIDE | 2GM/4ML (500MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-07 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N210852-001 | 10849916 | 2035-07-13 | Drug product | 2023-06-27 | |
| N210852-001 | 11382923 | 2035-12-01 | Drug product | 2023-06-27 | |
| N210852-002 | 10849916 | 2035-07-13 | Drug product | 2023-06-27 | |
| N210852-002 | 11382923 | 2035-12-01 | Drug product | 2023-06-27 | |
| N210852-003 | 10849916 | 2035-07-13 | Drug product | 2023-06-27 | |
| N210852-003 | 11382923 | 2035-12-01 | Drug product | 2023-06-27 |
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 | N210852-001 | FRINDOVYX | 500MG/ML (500MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210852-002 | FRINDOVYX | 1GM/2ML (500MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210852-003 | FRINDOVYX | 2GM/4ML (500MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-07 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210852-001 | FRINDOVYX | 500MG/ML (500MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210852-002 | FRINDOVYX | 1GM/2ML (500MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210852-003 | FRINDOVYX | 2GM/4ML (500MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-07 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N210852-001 | CYCLOPHOSPHAMIDE | 500MG/ML (500MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N210852-002 | CYCLOPHOSPHAMIDE | 1GM/2ML (500MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N210852-003 | CYCLOPHOSPHAMIDE | 2GM/4ML (500MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-07 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210852-001 | CYCLOPHOSPHAMIDE | 500MG/ML (500MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210852-002 | CYCLOPHOSPHAMIDE | 1GM/2ML (500MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210852-003 | CYCLOPHOSPHAMIDE | 2GM/4ML (500MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-07 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210852-001 | CYCLOPHOSPHAMIDE | 500MG/ML (500MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210852-002 | CYCLOPHOSPHAMIDE | 1GM/2ML (500MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210852-003 | CYCLOPHOSPHAMIDE | 2GM/4ML (500MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-07 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N210852-001 | CYCLOPHOSPHAMIDE | 500MG/ML (500MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N210852-002 | CYCLOPHOSPHAMIDE | 1GM/2ML (500MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N210852-003 | CYCLOPHOSPHAMIDE | 2GM/4ML (500MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-07 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N210852-001 | CYCLOPHOSPHAMIDE | 500MG/ML (500MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N210852-002 | CYCLOPHOSPHAMIDE | 1GM/2ML (500MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N210852-003 | CYCLOPHOSPHAMIDE | 2GM/4ML (500MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-07 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N210852-001 | CYCLOPHOSPHAMIDE | 500MG/ML (500MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N210852-002 | CYCLOPHOSPHAMIDE | 1GM/2ML (500MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N210852-003 | CYCLOPHOSPHAMIDE | 2GM/4ML (500MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-07 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N210852-001 | CYCLOPHOSPHAMIDE | 500MG/ML (500MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N210852-002 | CYCLOPHOSPHAMIDE | 1GM/2ML (500MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N210852-003 | CYCLOPHOSPHAMIDE | 2GM/4ML (500MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-07 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N210852-001 | CYCLOPHOSPHAMIDE | 500MG/ML (500MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N210852-002 | CYCLOPHOSPHAMIDE | 1GM/2ML (500MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N210852-003 | CYCLOPHOSPHAMIDE | 2GM/4ML (500MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-07 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N210852-001 | CYCLOPHOSPHAMIDE | 500MG/ML (500MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-07 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N210852-002 | CYCLOPHOSPHAMIDE | 1GM/2ML (500MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-07 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N210852-003 | CYCLOPHOSPHAMIDE | 2GM/4ML (500MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-07 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N210852-001 | CYCLOPHOSPHAMIDE | 500MG/ML (500MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-07 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N210852-002 | CYCLOPHOSPHAMIDE | 1GM/2ML (500MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-07 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N210852-003 | CYCLOPHOSPHAMIDE | 2GM/4ML (500MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-07 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N210852-001 | CYCLOPHOSPHAMIDE | 500MG/ML (500MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-07 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N210852-002 | CYCLOPHOSPHAMIDE | 1GM/2ML (500MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-07 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N210852-003 | CYCLOPHOSPHAMIDE | 2GM/4ML (500MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-07 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N210852-001 | CYCLOPHOSPHAMIDE | 500MG/ML (500MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2023-06-07 | 8072bd15b7f6… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N210852-001 | 10849916 | 2035-07-13 | Drug product | 2023-06-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210852-001 | 11382923 | 2035-12-01 | Drug product | 2023-06-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210852-002 | 10849916 | 2035-07-13 | Drug product | 2023-06-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210852-002 | 11382923 | 2035-12-01 | Drug product | 2023-06-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210852-003 | 10849916 | 2035-07-13 | Drug product | 2023-06-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N210852-003 | 11382923 | 2035-12-01 | Drug product | 2023-06-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210852-001 | 10849916 | 2035-07-13 | Drug product | 2023-06-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210852-001 | 11382923 | 2035-12-01 | Drug product | 2023-06-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210852-002 | 10849916 | 2035-07-13 | Drug product | 2023-06-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210852-002 | 11382923 | 2035-12-01 | Drug product | 2023-06-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210852-003 | 10849916 | 2035-07-13 | Drug product | 2023-06-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N210852-003 | 11382923 | 2035-12-01 | Drug product | 2023-06-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N210852-001 | 10849916 | 2035-07-13 | Drug product | 2023-06-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N210852-001 | 11382923 | 2035-12-01 | Drug product | 2023-06-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N210852-002 | 10849916 | 2035-07-13 | Drug product | 2023-06-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N210852-002 | 11382923 | 2035-12-01 | Drug product | 2023-06-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N210852-003 | 10849916 | 2035-07-13 | Drug product | 2023-06-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N210852-003 | 11382923 | 2035-12-01 | Drug product | 2023-06-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210852-001 | 10849916 | 2035-07-13 | Drug product | 2023-06-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210852-001 | 11382923 | 2035-12-01 | Drug product | 2023-06-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210852-002 | 10849916 | 2035-07-13 | Drug product | 2023-06-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210852-002 | 11382923 | 2035-12-01 | Drug product | 2023-06-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210852-003 | 10849916 | 2035-07-13 | Drug product | 2023-06-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N210852-003 | 11382923 | 2035-12-01 | Drug product | 2023-06-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210852-001 | 10849916 | 2035-07-13 | Drug product | 2023-06-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210852-001 | 11382923 | 2035-12-01 | Drug product | 2023-06-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210852-002 | 10849916 | 2035-07-13 | Drug product | 2023-06-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210852-002 | 11382923 | 2035-12-01 | Drug product | 2023-06-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210852-003 | 10849916 | 2035-07-13 | Drug product | 2023-06-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N210852-003 | 11382923 | 2035-12-01 | Drug product | 2023-06-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N210852-001 | 10849916 | 2035-07-13 | Drug product | 2023-06-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N210852-001 | 11382923 | 2035-12-01 | Drug product | 2023-06-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N210852-002 | 10849916 | 2035-07-13 | Drug product | 2023-06-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N210852-002 | 11382923 | 2035-12-01 | Drug product | 2023-06-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N210852-003 | 10849916 | 2035-07-13 | Drug product | 2023-06-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N210852-003 | 11382923 | 2035-12-01 | Drug product | 2023-06-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N210852-001 | 10849916 | 2035-07-13 | Drug product | 2023-06-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N210852-001 | 11382923 | 2035-12-01 | Drug product | 2023-06-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N210852-002 | 10849916 | 2035-07-13 | Drug product | 2023-06-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N210852-002 | 11382923 | 2035-12-01 | Drug product | 2023-06-27 | 2680178bc6a6… |
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 |
|---|---|---|---|---|---|---|
| Frindovyx | CYCLOPHOSPHAMIDE | Avyxa Pharma, LLC | 5ad8ea65-4c98-487a-9c8d-df778765ec5e | 2025-08-11 | Warnings, Adverse reactions | 210852 NDA210852 |
| Cyclophosphamide | CYCLOPHOSPHAMIDE | Avyxa Pharma, LLC | 6f593585-e0dd-48bc-bd2b-c6c787e0b98c | 2024-07-26 | Warnings, Adverse reactions | 210852 NDA210852 |