Application 021335
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GLEEVEC | IMATINIB MESYLATE | CAPSULE;ORAL | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | GLEEVEC | IMATINIB MESYLATE | CAPSULE;ORAL | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021335-001 | GLEEVEC | IMATINIB MESYLATE | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-05-10 | |
| N021335-002 | GLEEVEC | IMATINIB MESYLATE | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-05-10 |
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| 2026-08 | N021335-001 | GLEEVEC | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-05-10 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021335-002 | GLEEVEC | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-05-10 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021335-001 | GLEEVEC | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-05-10 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021335-002 | GLEEVEC | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-05-10 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021335-001 | GLEEVEC | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-05-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021335-002 | GLEEVEC | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-05-10 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021335-001 | GLEEVEC | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-05-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021335-002 | GLEEVEC | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-05-10 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021335-001 | GLEEVEC | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-05-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021335-002 | GLEEVEC | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-05-10 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021335-001 | GLEEVEC | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-05-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021335-002 | GLEEVEC | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-05-10 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021335-001 | GLEEVEC | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-05-10 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021335-002 | GLEEVEC | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-05-10 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021335-001 | GLEEVEC | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-05-10 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021335-002 | GLEEVEC | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-05-10 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021335-001 | GLEEVEC | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-05-10 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021335-002 | GLEEVEC | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-05-10 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021335-001 | GLEEVEC | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-05-10 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021335-002 | GLEEVEC | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-05-10 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021335-001 | GLEEVEC | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-05-10 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021335-002 | GLEEVEC | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-05-10 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021335-001 | GLEEVEC | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-05-10 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021335-002 | GLEEVEC | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-05-10 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021335-001 | GLEEVEC | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-05-10 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021335-002 | GLEEVEC | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-05-10 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021335-001 | GLEEVEC | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-05-10 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021335-002 | GLEEVEC | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-05-10 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021335-001 | GLEEVEC | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-05-10 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021335-002 | GLEEVEC | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-05-10 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021335-001 | GLEEVEC | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-05-10 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021335-002 | GLEEVEC | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-05-10 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021335-001 | GLEEVEC | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-05-10 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021335-002 | GLEEVEC | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2001-05-10 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021335-001 | GLEEVEC | EQ 50MG BASE | CAPSULE / ORAL | RLD | 2001-05-10 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021335-002 | GLEEVEC | EQ 100MG BASE | CAPSULE / ORAL | RLD | 2001-05-10 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021335-001 | GLEEVEC | EQ 50MG BASE | CAPSULE / ORAL | RLD | 2001-05-10 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021335-002 | GLEEVEC | EQ 100MG BASE | CAPSULE / ORAL | RLD | 2001-05-10 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021335-001 | GLEEVEC | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE / ORAL | RLD | 2001-05-10 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021335-002 | GLEEVEC | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE / ORAL | RLD | 2001-05-10 | 74a2ff9319b5… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021335-001 | 6958335*PED | 2022-06-19 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021335-002 | 6958335*PED | 2022-06-19 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021335-001 | 6958335*PED | 2022-06-19 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021335-002 | 6958335*PED | 2022-06-19 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N021335-001 | 6958335*PED | 2022-06-19 | Pediatric extension | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N021335-002 | 6958335*PED | 2022-06-19 | Pediatric extension | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021335-001 | RE43932*PED | 2019-01-16 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021335-001 | 6894051 | 2019-05-23 | U-649 | Drug substance, Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021335-001 | 6894051*PED | 2019-11-23 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021335-001 | 6958335 | 2021-12-19 | U-791 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021335-001 | 6958335*PED | 2022-06-19 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021335-002 | RE43932*PED | 2019-01-16 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021335-002 | 6894051 | 2019-05-23 | U-649 | Drug substance, Drug product | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021335-002 | 6894051*PED | 2019-11-23 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021335-002 | 6958335 | 2021-12-19 | U-791 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021335-002 | 6958335*PED | 2022-06-19 | Pediatric extension | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N021335-001 | 6958335*PED | 2022-06-19 | Pediatric extension | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N021335-002 | 6958335*PED | 2022-06-19 | Pediatric extension | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021335-001 | 6958335 | 2021-12-19 | U-791 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021335-001 | 6958335*PED | 2022-06-19 | Pediatric extension | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021335-002 | 6958335 | 2021-12-19 | U-791 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021335-002 | 6958335*PED | 2022-06-19 | Pediatric extension | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021335-001 | 6958335 | 2021-12-19 | U-791 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021335-001 | 6958335*PED | 2022-06-19 | Pediatric extension | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021335-002 | 6958335 | 2021-12-19 | U-791 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021335-002 | 6958335*PED | 2022-06-19 | Pediatric extension | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N021335-001 | 6958335 | 2021-12-19 | U-791 | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N021335-001 | 6958335*PED | 2022-06-19 | Pediatric extension | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N021335-002 | 6958335 | 2021-12-19 | U-791 | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N021335-002 | 6958335*PED | 2022-06-19 | Pediatric extension | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021335-001 | 6958335 | 2021-12-19 | U-791 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021335-001 | 6958335*PED | 2022-06-19 | Pediatric extension | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021335-002 | 6958335 | 2021-12-19 | U-791 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021335-002 | 6958335*PED | 2022-06-19 | Pediatric extension | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021335-001 | 6958335 | 2021-12-19 | U-791 | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021335-001 | 6958335*PED | 2022-06-19 | Pediatric extension | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021335-002 | 6958335 | 2021-12-19 | U-791 | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021335-002 | 6958335*PED | 2022-06-19 | Pediatric extension | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021335-001 | RE43932*PED | 2019-01-16 | Pediatric extension | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021335-001 | 6894051 | 2019-05-23 | U-649 | Drug substance, Drug product | 3f01610625f2… |
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 | IMATINIB MESYLATE | Apotex Corp | 0291eca5-7a1d-4a79-30be-252224d96509 | 2026-09-08 | Warnings, Adverse reactions | IMATINIB MESYLATE |
| Imatinib Mesylate | IMATINIB MESYLATE | QUALLENT PHARMACEUTICALS HEALTH LLC | a819a954-41c9-4d49-a74e-c8c4b338b22a | 2026-08-27 | Warnings, Adverse reactions | IMATINIB MESYLATE |
| Imatinib Mesylate | IMATINIB MESYLATE | Major Pharmaceuticals | 7c037022-7fc8-4b6e-9db3-427206c572b4 | 2026-08-04 | Warnings, Adverse reactions | IMATINIB MESYLATE |
| Imatinib Mesylate | IMATINIB MESYLATE | Aurobindo Pharma Limited | a4e409f7-20b4-4c80-8a6a-f95995ffad78 | 2026-07-28 | Warnings, Adverse reactions | IMATINIB MESYLATE |
| Gleevec | IMATINIB MESYLATE | Novartis Pharmaceuticals Corporation | 211ef2da-2868-4a77-8055-1cb2cd78e24b | 2026-07-13 | Warnings, Adverse reactions | Gleevec IMATINIB MESYLATE |
| IMATINIB MESYLATE | IMATINIB MESYLATE | Civica Script LLC | 9fc5ec7b-98c4-4b1a-890c-be1343177dbd | 2026-07-03 | Warnings, Adverse reactions | IMATINIB MESYLATE |
| imatinib mesylate | IMATINIB MESYLATE | Sun Pharmaceutical Industries, Inc. | 07764bf9-21b4-4e32-9d7e-e348f8e4291f | 2026-06-01 | Warnings, Adverse reactions | IMATINIB MESYLATE |
| Imatinib Mesylate | IMATINIB MESYLATE | BluePoint Laboratories | c0611fc0-b217-4988-acd4-b8c629ce489b | 2026-05-21 | Warnings, Adverse reactions | IMATINIB MESYLATE |
| Imatinib Mesylate | IMATINIB MESYLATE | Teva Pharmaceuticals USA, Inc. | a9cfc301-3c7f-4910-8813-41dcb0b4ca69 | 2026-04-29 | Warnings, Adverse reactions | IMATINIB MESYLATE |
| imatinib mesylate | IMATINIB MESYLATE | Upsher-Smith Laboratories, LLC | 5d07ac08-962e-41a8-8a3c-50febc8c5f34 | 2026-01-09 | Warnings, Adverse reactions | IMATINIB MESYLATE |
| Imatinib Mesylate | IMATINIB MESYLATE | Chartwell RX, LLC | 65b4d8a6-349d-4fb1-9818-dad6b4ad4fa1 | 2025-12-10 | Warnings, Adverse reactions | IMATINIB MESYLATE |
| IMATINIB MESYLATE | IMATINIB MESYLATE | Camber Pharmaceuticals, Inc. | e97f0238-b9da-46af-83a3-0826e39893e8 | 2025-11-25 | Warnings, Adverse reactions | IMATINIB MESYLATE |
| Imatinib Mesylate | IMATINIB MESYLATE | American Health Packaging | 6e7ed4ef-24e3-4545-9a99-2e34c946e8e7 | 2025-02-19 | Warnings, Adverse reactions | IMATINIB MESYLATE |
| imatinib mesylate | IMATINIB MESYLATE | Qilu Pharmaceutical Co., Ltd. | 82eb01e0-8685-4f06-8a72-7663e8ded38f | 2024-12-04 | Warnings, Adverse reactions | IMATINIB MESYLATE |
| imatinib mesylate | IMATINIB MESYLATE | BluePoint Laboratories | be5b9047-155b-59ca-e053-2995a90ad3dc | 2023-09-21 | Warnings, Adverse reactions | IMATINIB MESYLATE |
| imatinib mesylate | IMATINIB MESYLATE | Archis Pharma LLC | 9de8d8b9-cf88-4960-82b7-89e5ceb7720e | 2023-09-21 | Warnings, Adverse reactions | IMATINIB MESYLATE |
| 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 | Ascend Laboratories, LLC | 7579620e-3748-46fa-8295-f9b47d0aa5b8 | 2019-02-01 | Warnings, Adverse reactions | IMATINIB MESYLATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 42106 | SUPPL | 2004-09-29 |
| 21606 | SUPPL | 2004-08-09 |
| 5067 | SUPPL | 2004-06-04 |
| 44117 | ORIG | 2003-12-09 |
| 5068 | SUPPL | 2003-11-25 |
| 27505 | SUPPL | 2003-07-23 |
| 42105 | SUPPL | 2003-07-08 |
| 21605 | SUPPL | 2003-07-08 |
| 36678 | SUPPL | 2003-05-20 |
| 36677 | SUPPL | 2003-04-09 |
| 36679 | SUPPL | 2002-12-20 |
| 36676 | SUPPL | 2002-02-01 |
| 27504 | SUPPL | 2002-02-01 |
| 21604 | ORIG | 2001-05-10 |
| 15209 | ORIG | 2001-05-10 |
| 5066 | ORIG | 2001-05-10 |