Application 218544
- Type
- ANDA
- Sponsor
- MSN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NILOTINIB HYDROCHLORIDE | NILOTINIB HYDROCHLORIDE | CAPSULE;ORAL | EQ 50MG BASE | No | No |
| 002 | NILOTINIB HYDROCHLORIDE | NILOTINIB HYDROCHLORIDE | CAPSULE;ORAL | EQ 150MG BASE | No | No |
| 003 | NILOTINIB HYDROCHLORIDE | NILOTINIB HYDROCHLORIDE | CAPSULE;ORAL | EQ 200MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A218544-001 | NILOTINIB HYDROCHLORIDE | NILOTINIB HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2025-11-19 | |
| A218544-002 | NILOTINIB HYDROCHLORIDE | NILOTINIB HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2025-11-19 | |
| A218544-003 | NILOTINIB HYDROCHLORIDE | NILOTINIB HYDROCHLORIDE | EQ 200MG BASE | CAPSULE / ORAL | AB | 2025-11-19 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A218544-001 | AB |
| A218544-002 | AB |
| A218544-003 | AB |
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 | A218544-001 | NILOTINIB HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2025-11-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A218544-002 | NILOTINIB HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2025-11-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A218544-003 | NILOTINIB HYDROCHLORIDE | EQ 200MG BASE | CAPSULE / ORAL | AB | 2025-11-19 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218544-001 | NILOTINIB HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2025-11-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218544-002 | NILOTINIB HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2025-11-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218544-003 | NILOTINIB HYDROCHLORIDE | EQ 200MG BASE | CAPSULE / ORAL | AB | 2025-11-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218544-001 | NILOTINIB HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2025-11-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218544-002 | NILOTINIB HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2025-11-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218544-003 | NILOTINIB HYDROCHLORIDE | EQ 200MG BASE | CAPSULE / ORAL | AB | 2025-11-19 | 31067a03dcf5… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218544-001 | NILOTINIB HYDROCHLORIDE | EQ 50MG BASE | CAPSULE / ORAL | AB | 2025-11-19 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218544-002 | NILOTINIB HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2025-11-19 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218544-003 | NILOTINIB HYDROCHLORIDE | EQ 200MG BASE | CAPSULE / ORAL | AB | 2025-11-19 | 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 | A218544-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A218544-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A218544-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A218544-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A218544-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A218544-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218544-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218544-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218544-003 | AB | 1 | 31067a03dcf5… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218544-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218544-002 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218544-003 | AB | 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 |
|---|---|---|---|---|---|---|
| nilotinib | NILOTINIB | AvKARE | 4c0bc799-ce6a-822a-e063-6394a90ab748 | 2026-03-02 | Boxed warning, Warnings, Adverse reactions | 218544 ANDA218544 |
| nilotinib | NILOTINIB | Novadoz Pharmaceuticals LLC | 13b46e09-62d2-4ce9-b3c0-deafcb1f1842 | 2025-11-20 | Boxed warning, Warnings, Adverse reactions | 218544 ANDA218544 |