Application 218922
- Type
- NDA
- Sponsor
- CIPLA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NILOTINIB D-TARTRATE | NILOTINIB D-TARTRATE | CAPSULE;ORAL | EQ 50MG BASE | Yes | No |
| 002 | NILOTINIB D-TARTRATE | NILOTINIB D-TARTRATE | CAPSULE;ORAL | EQ 150MG BASE | Yes | No |
| 003 | NILOTINIB D-TARTRATE | NILOTINIB D-TARTRATE | CAPSULE;ORAL | EQ 200MG BASE | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N218922-001 | NILOTINIB D-TARTRATE | NILOTINIB D-TARTRATE | EQ 50MG BASE | CAPSULE / ORAL | RLD | 2025-02-19 | |
| N218922-002 | NILOTINIB D-TARTRATE | NILOTINIB D-TARTRATE | EQ 150MG BASE | CAPSULE / ORAL | RLD | 2025-02-19 | |
| N218922-003 | NILOTINIB D-TARTRATE | NILOTINIB D-TARTRATE | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2025-02-19 |
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 | N218922-001 | NILOTINIB D-TARTRATE | EQ 50MG BASE | CAPSULE / ORAL | RLD | 2025-02-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N218922-002 | NILOTINIB D-TARTRATE | EQ 150MG BASE | CAPSULE / ORAL | RLD | 2025-02-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N218922-003 | NILOTINIB D-TARTRATE | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2025-02-19 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N218922-001 | NILOTINIB D-TARTRATE | EQ 50MG BASE | CAPSULE / ORAL | RLD | 2025-02-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N218922-002 | NILOTINIB D-TARTRATE | EQ 150MG BASE | CAPSULE / ORAL | RLD | 2025-02-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N218922-003 | NILOTINIB D-TARTRATE | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2025-02-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N218922-001 | NILOTINIB D-TARTRATE | EQ 50MG BASE | CAPSULE / ORAL | RLD | 2025-02-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N218922-002 | NILOTINIB D-TARTRATE | EQ 150MG BASE | CAPSULE / ORAL | RLD | 2025-02-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N218922-003 | NILOTINIB D-TARTRATE | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2025-02-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N218922-001 | NILOTINIB D-TARTRATE | EQ 50MG BASE | CAPSULE / ORAL | RLD | 2025-02-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N218922-002 | NILOTINIB D-TARTRATE | EQ 150MG BASE | CAPSULE / ORAL | RLD | 2025-02-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N218922-003 | NILOTINIB D-TARTRATE | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2025-02-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N218922-001 | NILOTINIB D-TARTRATE | EQ 50MG BASE | CAPSULE / ORAL | RLD | 2025-02-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N218922-002 | NILOTINIB D-TARTRATE | EQ 150MG BASE | CAPSULE / ORAL | RLD | 2025-02-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N218922-003 | NILOTINIB D-TARTRATE | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2025-02-19 | fd3edfee7708… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N218922-001 | NILOTINIB D-TARTRATE | EQ 50MG BASE | CAPSULE / ORAL | RLD | 2025-02-19 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N218922-002 | NILOTINIB D-TARTRATE | EQ 150MG BASE | CAPSULE / ORAL | RLD | 2025-02-19 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N218922-003 | NILOTINIB D-TARTRATE | EQ 200MG BASE | CAPSULE / ORAL | RLD, RS | 2025-02-19 | 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 |
|---|---|---|---|---|---|---|
| Nilotinib | NILOTINIB | EXELAN PHARMACEUTICALS INC. | 3c67b81f-9a44-446a-a24f-bbecbbf88979 | 2025-11-14 | Boxed warning, Warnings, Adverse reactions | 218922 NDA218922 |
| Nilotinib | NILOTINIB | Cipla USA Inc. | e27c3e09-bc4f-4f01-be05-1c43ac72285d | 2025-07-02 | Boxed warning, Warnings, Adverse reactions | 218922 NDA218922 |