Application 215893
- Type
- ANDA
- Sponsor
- APOTEX
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PONATINIB HYDROCHLORIDE | PONATINIB HYDROCHLORIDE | TABLET;ORAL | EQ 15MG BASE | No | No |
| 002 | PONATINIB HYDROCHLORIDE | PONATINIB HYDROCHLORIDE | TABLET;ORAL | EQ 45MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A215893-001 | PONATINIB HYDROCHLORIDE | PONATINIB HYDROCHLORIDE | EQ 15MG BASE | TABLET / ORAL | 2023-07-14 | ||
| A215893-002 | PONATINIB HYDROCHLORIDE | PONATINIB HYDROCHLORIDE | EQ 45MG BASE | TABLET / ORAL | 2023-07-14 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A215893-001 | PONATINIB HYDROCHLORIDE | EQ 15MG BASE | TABLET / ORAL | 2023-07-14 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A215893-002 | PONATINIB HYDROCHLORIDE | EQ 45MG BASE | TABLET / ORAL | 2023-07-14 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A215893-001 | PONATINIB HYDROCHLORIDE | EQ 15MG BASE | TABLET / ORAL | 2023-07-14 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A215893-002 | PONATINIB HYDROCHLORIDE | EQ 45MG BASE | TABLET / ORAL | 2023-07-14 | 9b2671bbb829… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A215893-001 | PONATINIB HYDROCHLORIDE | EQ 15MG BASE | TABLET / ORAL | 2023-07-14 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A215893-002 | PONATINIB HYDROCHLORIDE | EQ 45MG BASE | TABLET / ORAL | 2023-07-14 | 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 |
|---|---|---|---|---|---|---|
| Iclusig | PONATINIB HYDROCHLORIDE | Takeda Pharmaceuticals America, Inc. | 16d804b6-4957-43ee-b18c-3b36ec37c5ac | 2026-08-14 | Boxed warning, Warnings, Adverse reactions | PONATINIB HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.