Application 212193
- Type
- ANDA
- Sponsor
- CSPC OUYI
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | IMATINIB MESYLATE | IMATINIB MESYLATE | TABLET;ORAL | EQ 100MG BASE | No | No |
| 002 | IMATINIB MESYLATE | IMATINIB MESYLATE | TABLET;ORAL | EQ 400MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A212193-001 | IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 100MG BASE | TABLET / ORAL | AB | 2025-04-21 | |
| A212193-002 | IMATINIB MESYLATE | IMATINIB MESYLATE | EQ 400MG BASE | TABLET / ORAL | AB | 2025-04-21 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A212193-001 | AB |
| A212193-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A212193-001 | IMATINIB MESYLATE | EQ 100MG BASE | TABLET / ORAL | AB | 2025-04-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A212193-002 | IMATINIB MESYLATE | EQ 400MG BASE | TABLET / ORAL | AB | 2025-04-21 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A212193-001 | IMATINIB MESYLATE | EQ 100MG BASE | TABLET / ORAL | AB | 2025-04-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A212193-002 | IMATINIB MESYLATE | EQ 400MG BASE | TABLET / ORAL | AB | 2025-04-21 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212193-001 | IMATINIB MESYLATE | EQ 100MG BASE | TABLET / ORAL | AB | 2025-04-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212193-002 | IMATINIB MESYLATE | EQ 400MG BASE | TABLET / ORAL | AB | 2025-04-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212193-001 | IMATINIB MESYLATE | EQ 100MG BASE | TABLET / ORAL | AB | 2025-04-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212193-002 | IMATINIB MESYLATE | EQ 400MG BASE | TABLET / ORAL | AB | 2025-04-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212193-001 | IMATINIB MESYLATE | EQ 100MG BASE | TABLET / ORAL | AB | 2025-04-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212193-002 | IMATINIB MESYLATE | EQ 400MG BASE | TABLET / ORAL | AB | 2025-04-21 | 6a471c1ec25d… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A212193-001 | IMATINIB MESYLATE | EQ 100MG BASE | TABLET / ORAL | AB | 2025-04-21 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A212193-002 | IMATINIB MESYLATE | EQ 400MG BASE | TABLET / ORAL | AB | 2025-04-21 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A212193-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A212193-002 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A212193-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A212193-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A212193-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A212193-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212193-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212193-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A212193-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A212193-002 | AB | 1 | 6a471c1ec25d… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A212193-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A212193-002 | 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 |
|---|---|---|---|---|---|---|
| Imatinib mesylate 400 mg | IMATINIB MESYLATE | Armas Pharmaceuticals Inc. | 7b7cc194-29e4-4484-a364-a1ac7d7d6cf5 | 2019-03-08 | Warnings, Adverse reactions | IMATINIB MESYLATE |
| Imatinib mesylate | IMATINIB MESYLATE | Armas Pharmaceuticals Inc. | 2e931c49-6c9f-41e2-a34b-5f01cd295b56 | 2019-03-04 | Warnings, Adverse reactions | Imatinib mesylate IMATINIB MESYLATE |
| Imatinib mesylate | IMATINIB MESYLATE | Ascend Laboratories, LLC | 7579620e-3748-46fa-8295-f9b47d0aa5b8 | 2019-02-01 | Warnings, Adverse reactions | Imatinib mesylate IMATINIB MESYLATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.