PHYRAGO
- Product NDC
- 70709-155
- 11-digit product format
- 707090155
- Labeler code
- 70709
- Product ID
- 70709-155_c853d4c8-8373-4603-bc62-41e53130c0aa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dasatinib
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Cycle Pharmaceuticals Ltd
- Application
- NDA216099
- Marketing category
- NDA
- Marketing start
- 2025-09-22
- Substance
- DASATINIB
- Active strength
- 100 mg/1
- Pharmacologic classes
- Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N216099-001 | PHYRAGO | DASATINIB | 20MG | TABLET / ORAL | RLD | 2023-12-05 | |
| N216099-002 | PHYRAGO | DASATINIB | 50MG | TABLET / ORAL | RLD | 2023-12-05 | |
| N216099-003 | PHYRAGO | DASATINIB | 70MG | TABLET / ORAL | RLD | 2023-12-05 | |
| N216099-004 | PHYRAGO | DASATINIB | 80MG | TABLET / ORAL | RLD | 2023-12-05 | |
| N216099-005 | PHYRAGO | DASATINIB | 100MG | TABLET / ORAL | RLD, RS | 2023-12-05 | |
| N216099-006 | PHYRAGO | DASATINIB | 140MG | TABLET / ORAL | RLD | 2023-12-05 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N216099-001 | 11202778 | 2041-01-22 | U-3770 | 2023-12-22 | |
| N216099-001 | 11202778 | 2041-01-22 | U-3771 | 2023-12-22 | |
| N216099-001 | 11202778 | 2041-01-22 | U-3772 | 2023-12-22 | |
| N216099-001 | 11298356 | 2041-01-22 | Drug product | 2023-12-22 | |
| N216099-001 | 11324745 | 2041-01-22 | U-3767 | 2023-12-22 | |
| N216099-001 | 11324745 | 2041-01-22 | U-3768 | 2023-12-22 | |
| N216099-001 | 11324745 | 2041-01-22 | U-3769 | 2023-12-22 | |
| N216099-001 | 12433891 | 2041-01-22 | U-3767 | 2025-10-21 | |
| N216099-001 | 12433891 | 2041-01-22 | U-3768 | 2025-10-21 | |
| N216099-001 | 12433891 | 2041-01-22 | U-3769 | 2025-10-21 | |
| N216099-001 | 12433891 | 2041-01-22 | U-3770 | 2025-10-21 | |
| N216099-001 | 12433891 | 2041-01-22 | U-3771 | 2025-10-21 | |
| N216099-001 | 12433891 | 2041-01-22 | U-3772 | 2025-10-21 | |
| N216099-001 | 12465606 | 2041-01-22 | Drug product | 2025-11-14 | |
| N216099-001 | 12544376 | 2041-01-22 | U-3767 | 2026-02-17 | |
| N216099-001 | 12544376 | 2041-01-22 | U-3768 | 2026-02-17 | |
| N216099-001 | 12544376 | 2041-01-22 | U-3769 | 2026-02-17 | |
| N216099-001 | 12544376 | 2041-01-22 | U-3770 | 2026-02-17 | |
| N216099-001 | 12544376 | 2041-01-22 | U-3771 | 2026-02-17 | |
| N216099-001 | 12544376 | 2041-01-22 | U-3772 | 2026-02-17 | |
| N216099-002 | 11202778 | 2041-01-22 | U-3770 | 2023-12-22 | |
| N216099-002 | 11202778 | 2041-01-22 | U-3771 | 2023-12-22 | |
| N216099-002 | 11202778 | 2041-01-22 | U-3772 | 2023-12-22 | |
| N216099-002 | 11298356 | 2041-01-22 | Drug product | 2023-12-22 | |
| N216099-002 | 11324745 | 2041-01-22 | U-3767 | 2023-12-22 | |
| N216099-002 | 11324745 | 2041-01-22 | U-3768 | 2023-12-22 | |
| N216099-002 | 11324745 | 2041-01-22 | U-3769 | 2023-12-22 | |
| N216099-002 | 12433891 | 2041-01-22 | U-3767 | 2025-10-21 | |
| N216099-002 | 12433891 | 2041-01-22 | U-3768 | 2025-10-21 | |
| N216099-002 | 12433891 | 2041-01-22 | U-3769 | 2025-10-21 | |
| N216099-002 | 12433891 | 2041-01-22 | U-3770 | 2025-10-21 | |
| N216099-002 | 12433891 | 2041-01-22 | U-3771 | 2025-10-21 | |
| N216099-002 | 12433891 | 2041-01-22 | U-3772 | 2025-10-21 | |
| N216099-002 | 12465606 | 2041-01-22 | Drug product | 2025-11-14 | |
| N216099-002 | 12544376 | 2041-01-22 | U-3767 | 2026-02-17 | |
| N216099-002 | 12544376 | 2041-01-22 | U-3768 | 2026-02-17 | |
| N216099-002 | 12544376 | 2041-01-22 | U-3769 | 2026-02-17 | |
| N216099-002 | 12544376 | 2041-01-22 | U-3770 | 2026-02-17 | |
| N216099-002 | 12544376 | 2041-01-22 | U-3771 | 2026-02-17 | |
| N216099-002 | 12544376 | 2041-01-22 | U-3772 | 2026-02-17 | |
| N216099-003 | 11202778 | 2041-01-22 | U-3770 | 2023-12-22 | |
| N216099-003 | 11202778 | 2041-01-22 | U-3771 | 2023-12-22 | |
| N216099-003 | 11202778 | 2041-01-22 | U-3772 | 2023-12-22 | |
| N216099-003 | 11298356 | 2041-01-22 | Drug product | 2023-12-22 | |
| N216099-003 | 11324745 | 2041-01-22 | U-3767 | 2023-12-22 | |
| N216099-003 | 11324745 | 2041-01-22 | U-3768 | 2023-12-22 | |
| N216099-003 | 11324745 | 2041-01-22 | U-3769 | 2023-12-22 | |
| N216099-003 | 12433891 | 2041-01-22 | U-3767 | 2025-10-21 | |
| N216099-003 | 12433891 | 2041-01-22 | U-3768 | 2025-10-21 | |
| N216099-003 | 12433891 | 2041-01-22 | U-3769 | 2025-10-21 | |
| N216099-003 | 12433891 | 2041-01-22 | U-3770 | 2025-10-21 | |
| N216099-003 | 12433891 | 2041-01-22 | U-3771 | 2025-10-21 | |
| N216099-003 | 12433891 | 2041-01-22 | U-3772 | 2025-10-21 | |
| N216099-003 | 12465606 | 2041-01-22 | Drug product | 2025-11-14 | |
| N216099-003 | 12544376 | 2041-01-22 | U-3767 | 2026-02-17 | |
| N216099-003 | 12544376 | 2041-01-22 | U-3768 | 2026-02-17 | |
| N216099-003 | 12544376 | 2041-01-22 | U-3769 | 2026-02-17 | |
| N216099-003 | 12544376 | 2041-01-22 | U-3770 | 2026-02-17 | |
| N216099-003 | 12544376 | 2041-01-22 | U-3771 | 2026-02-17 | |
| N216099-003 | 12544376 | 2041-01-22 | U-3772 | 2026-02-17 | |
| N216099-004 | 11202778 | 2041-01-22 | U-3770 | 2023-12-22 | |
| N216099-004 | 11202778 | 2041-01-22 | U-3771 | 2023-12-22 | |
| N216099-004 | 11202778 | 2041-01-22 | U-3772 | 2023-12-22 | |
| N216099-004 | 11298356 | 2041-01-22 | Drug product | 2023-12-22 | |
| N216099-004 | 11324745 | 2041-01-22 | U-3767 | 2023-12-22 | |
| N216099-004 | 11324745 | 2041-01-22 | U-3768 | 2023-12-22 | |
| N216099-004 | 11324745 | 2041-01-22 | U-3769 | 2023-12-22 | |
| N216099-004 | 12433891 | 2041-01-22 | U-3767 | 2025-10-21 | |
| N216099-004 | 12433891 | 2041-01-22 | U-3768 | 2025-10-21 | |
| N216099-004 | 12433891 | 2041-01-22 | U-3769 | 2025-10-21 | |
| N216099-004 | 12433891 | 2041-01-22 | U-3770 | 2025-10-21 | |
| N216099-004 | 12433891 | 2041-01-22 | U-3771 | 2025-10-21 | |
| N216099-004 | 12433891 | 2041-01-22 | U-3772 | 2025-10-21 | |
| N216099-004 | 12465606 | 2041-01-22 | Drug product | 2025-11-14 | |
| N216099-004 | 12544376 | 2041-01-22 | U-3767 | 2026-02-17 | |
| N216099-004 | 12544376 | 2041-01-22 | U-3768 | 2026-02-17 | |
| N216099-004 | 12544376 | 2041-01-22 | U-3769 | 2026-02-17 | |
| N216099-004 | 12544376 | 2041-01-22 | U-3770 | 2026-02-17 | |
| N216099-004 | 12544376 | 2041-01-22 | U-3771 | 2026-02-17 | |
| N216099-004 | 12544376 | 2041-01-22 | U-3772 | 2026-02-17 |
Orange Book exclusivity#
| Application-product | Exclusivity code | Expiration |
|---|---|---|
| N216099-001 | M-307 | 2026-12-05 |
| N216099-002 | M-307 | 2026-12-05 |
| N216099-003 | M-307 | 2026-12-05 |
| N216099-004 | M-307 | 2026-12-05 |
| N216099-005 | M-307 | 2026-12-05 |
| N216099-006 | M-307 | 2026-12-05 |
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 | N216099-001 | PHYRAGO | 20MG | TABLET / ORAL | RLD | 2023-12-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-002 | PHYRAGO | 50MG | TABLET / ORAL | RLD | 2023-12-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-003 | PHYRAGO | 70MG | TABLET / ORAL | RLD | 2023-12-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-004 | PHYRAGO | 80MG | TABLET / ORAL | RLD | 2023-12-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-005 | PHYRAGO | 100MG | TABLET / ORAL | RLD, RS | 2023-12-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-006 | PHYRAGO | 140MG | TABLET / ORAL | RLD | 2023-12-05 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216099-001 | PHYRAGO | 20MG | TABLET / ORAL | RLD | 2023-12-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216099-002 | PHYRAGO | 50MG | TABLET / ORAL | RLD | 2023-12-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216099-003 | PHYRAGO | 70MG | TABLET / ORAL | RLD | 2023-12-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216099-004 | PHYRAGO | 80MG | TABLET / ORAL | RLD | 2023-12-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216099-005 | PHYRAGO | 100MG | TABLET / ORAL | RLD, RS | 2023-12-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216099-006 | PHYRAGO | 140MG | TABLET / ORAL | RLD | 2023-12-05 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216099-001 | PHYRAGO | 20MG | TABLET / ORAL | RLD | 2023-12-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216099-002 | PHYRAGO | 50MG | TABLET / ORAL | RLD | 2023-12-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216099-003 | PHYRAGO | 70MG | TABLET / ORAL | RLD | 2023-12-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216099-004 | PHYRAGO | 80MG | TABLET / ORAL | RLD | 2023-12-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216099-005 | PHYRAGO | 100MG | TABLET / ORAL | RLD, RS | 2023-12-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N216099-006 | PHYRAGO | 140MG | TABLET / ORAL | RLD | 2023-12-05 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216099-001 | PHYRAGO | 20MG | TABLET / ORAL | RLD | 2023-12-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216099-002 | PHYRAGO | 50MG | TABLET / ORAL | RLD | 2023-12-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216099-003 | PHYRAGO | 70MG | TABLET / ORAL | RLD | 2023-12-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216099-004 | PHYRAGO | 80MG | TABLET / ORAL | RLD | 2023-12-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216099-005 | PHYRAGO | 100MG | TABLET / ORAL | RLD, RS | 2023-12-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216099-006 | PHYRAGO | 140MG | TABLET / ORAL | RLD | 2023-12-05 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216099-001 | PHYRAGO | 20MG | TABLET / ORAL | RLD | 2023-12-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216099-002 | PHYRAGO | 50MG | TABLET / ORAL | RLD | 2023-12-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216099-003 | PHYRAGO | 70MG | TABLET / ORAL | RLD | 2023-12-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216099-004 | PHYRAGO | 80MG | TABLET / ORAL | RLD | 2023-12-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216099-005 | PHYRAGO | 100MG | TABLET / ORAL | RLD, RS | 2023-12-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216099-006 | PHYRAGO | 140MG | TABLET / ORAL | RLD | 2023-12-05 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216099-001 | PHYRAGO | 20MG | TABLET / ORAL | RLD | 2023-12-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216099-002 | PHYRAGO | 50MG | TABLET / ORAL | RLD | 2023-12-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216099-003 | PHYRAGO | 70MG | TABLET / ORAL | RLD | 2023-12-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216099-004 | PHYRAGO | 80MG | TABLET / ORAL | RLD | 2023-12-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216099-005 | PHYRAGO | 100MG | TABLET / ORAL | RLD, RS | 2023-12-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216099-006 | PHYRAGO | 140MG | TABLET / ORAL | RLD | 2023-12-05 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216099-001 | PHYRAGO | 20MG | TABLET / ORAL | RLD | 2023-12-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216099-002 | PHYRAGO | 50MG | TABLET / ORAL | RLD | 2023-12-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216099-003 | PHYRAGO | 70MG | TABLET / ORAL | RLD | 2023-12-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216099-004 | PHYRAGO | 80MG | TABLET / ORAL | RLD | 2023-12-05 | 2680178bc6a6… |
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 | N216099-001 | 11202778 | 2041-01-22 | U-3770 | 2023-12-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-001 | 11202778 | 2041-01-22 | U-3771 | 2023-12-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-001 | 11202778 | 2041-01-22 | U-3772 | 2023-12-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-001 | 11298356 | 2041-01-22 | Drug product | 2023-12-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-001 | 11324745 | 2041-01-22 | U-3767 | 2023-12-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-001 | 11324745 | 2041-01-22 | U-3768 | 2023-12-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-001 | 11324745 | 2041-01-22 | U-3769 | 2023-12-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-001 | 12433891 | 2041-01-22 | U-3769 | 2025-10-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-001 | 12433891 | 2041-01-22 | U-3768 | 2025-10-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-001 | 12433891 | 2041-01-22 | U-3767 | 2025-10-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-001 | 12433891 | 2041-01-22 | U-3770 | 2025-10-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-001 | 12433891 | 2041-01-22 | U-3771 | 2025-10-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-001 | 12433891 | 2041-01-22 | U-3772 | 2025-10-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-001 | 12465606 | 2041-01-22 | Drug product | 2025-11-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-002 | 11202778 | 2041-01-22 | U-3770 | 2023-12-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-002 | 11202778 | 2041-01-22 | U-3771 | 2023-12-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-002 | 11202778 | 2041-01-22 | U-3772 | 2023-12-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-002 | 11298356 | 2041-01-22 | Drug product | 2023-12-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-002 | 11324745 | 2041-01-22 | U-3768 | 2023-12-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-002 | 11324745 | 2041-01-22 | U-3769 | 2023-12-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-002 | 11324745 | 2041-01-22 | U-3767 | 2023-12-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-002 | 12433891 | 2041-01-22 | U-3768 | 2025-10-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-002 | 12433891 | 2041-01-22 | U-3767 | 2025-10-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-002 | 12433891 | 2041-01-22 | U-3769 | 2025-10-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-002 | 12433891 | 2041-01-22 | U-3770 | 2025-10-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-002 | 12433891 | 2041-01-22 | U-3771 | 2025-10-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-002 | 12433891 | 2041-01-22 | U-3772 | 2025-10-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-002 | 12465606 | 2041-01-22 | Drug product | 2025-11-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-003 | 11202778 | 2041-01-22 | U-3770 | 2023-12-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-003 | 11202778 | 2041-01-22 | U-3771 | 2023-12-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-003 | 11202778 | 2041-01-22 | U-3772 | 2023-12-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-003 | 11298356 | 2041-01-22 | Drug product | 2023-12-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-003 | 11324745 | 2041-01-22 | U-3768 | 2023-12-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-003 | 11324745 | 2041-01-22 | U-3769 | 2023-12-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-003 | 11324745 | 2041-01-22 | U-3767 | 2023-12-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-003 | 12433891 | 2041-01-22 | U-3768 | 2025-10-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-003 | 12433891 | 2041-01-22 | U-3767 | 2025-10-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-003 | 12433891 | 2041-01-22 | U-3769 | 2025-10-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-003 | 12433891 | 2041-01-22 | U-3770 | 2025-10-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-003 | 12433891 | 2041-01-22 | U-3771 | 2025-10-21 | 011fe1cb6892… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N216099-001 | M-307 | 2026-12-05 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-002 | M-307 | 2026-12-05 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-003 | M-307 | 2026-12-05 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-004 | M-307 | 2026-12-05 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-005 | M-307 | 2026-12-05 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N216099-006 | M-307 | 2026-12-05 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216099-001 | M-307 | 2026-12-05 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216099-002 | M-307 | 2026-12-05 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216099-003 | M-307 | 2026-12-05 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216099-004 | M-307 | 2026-12-05 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216099-005 | M-307 | 2026-12-05 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N216099-006 | M-307 | 2026-12-05 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N216099-001 | M-307 | 2026-12-05 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216099-002 | M-307 | 2026-12-05 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216099-003 | M-307 | 2026-12-05 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216099-004 | M-307 | 2026-12-05 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216099-005 | M-307 | 2026-12-05 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N216099-006 | M-307 | 2026-12-05 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216099-001 | M-307 | 2026-12-05 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216099-002 | M-307 | 2026-12-05 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216099-003 | M-307 | 2026-12-05 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216099-004 | M-307 | 2026-12-05 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216099-005 | M-307 | 2026-12-05 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N216099-006 | M-307 | 2026-12-05 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216099-001 | M-307 | 2026-12-05 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216099-002 | M-307 | 2026-12-05 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216099-003 | M-307 | 2026-12-05 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216099-004 | M-307 | 2026-12-05 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216099-005 | M-307 | 2026-12-05 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N216099-006 | M-307 | 2026-12-05 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216099-001 | M-307 | 2026-12-05 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216099-002 | M-307 | 2026-12-05 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216099-003 | M-307 | 2026-12-05 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216099-004 | M-307 | 2026-12-05 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216099-005 | M-307 | 2026-12-05 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N216099-006 | M-307 | 2026-12-05 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216099-001 | M-307 | 2026-12-05 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216099-002 | M-307 | 2026-12-05 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216099-003 | M-307 | 2026-12-05 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N216099-004 | M-307 | 2026-12-05 | 2680178bc6a6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PHYRAGO
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DASATINIB | 100 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| RBZ1571X5H | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 643105 | Internal RxNorm lookup |
| 643107 | Internal RxNorm lookup |
| 643109 | Internal RxNorm lookup |
| 799047 | Internal RxNorm lookup |
| 1045402 | Internal RxNorm lookup |
| 1045406 | Internal RxNorm lookup |
| 2691837 | Internal RxNorm lookup |
| 2691839 | Internal RxNorm lookup |
| 2691841 | Internal RxNorm lookup |
| 2691843 | Internal RxNorm lookup |
| 2691845 | Internal RxNorm lookup |
| 2691847 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 60976d1e-c415-417f-8168-4e07999a7281 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b66e60ef-563e-ddb8-43b4-d625943af44b | Product name | 3 | 20251209 |
| 820d87d5-5779-4353-ae7e-33904df346a1 | Product name | 1 | 20241218 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70709-155-10 | PHYRAGO | 30 in 1 BOTTLE | TABLET | 30 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70709-155-10 | EA - Each | 70709-155 | f3ab31b7-0d17-4092-9935-8d36ba59af00 | 1 | 2025-10-14 |
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 |
|---|---|---|---|---|---|---|
| PHYRAGO | DASATINIB | Cycle Pharmaceuticals Ltd | 60976d1e-c415-417f-8168-4e07999a7281 | 2025-08-23 | Warnings, Adverse reactions | 216099 NDA216099 70709-155 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70709-155-10 | 70709015510 | 30 TABLET in 1 BOTTLE (70709-155-10) | 30 tablet | 2025-09-22 | No | No | Current |