FDA.reportPublic FDA data

Application 212193

Type
ANDA
Sponsor
CSPC OUYI

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IMATINIB MESYLATEIMATINIB MESYLATETABLET;ORALEQ 100MG BASENoNo
002IMATINIB MESYLATEIMATINIB MESYLATETABLET;ORALEQ 400MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212193-001IMATINIB MESYLATEIMATINIB MESYLATEEQ 100MG BASETABLET / ORALAB2025-04-21
A212193-002IMATINIB MESYLATEIMATINIB MESYLATEEQ 400MG BASETABLET / ORALAB2025-04-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A212193-001AB
A212193-002AB

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 table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A212193-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORALAB2025-04-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212193-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORALAB2025-04-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212193-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORALAB2025-04-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212193-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORALAB2025-04-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212193-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORALAB2025-04-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212193-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORALAB2025-04-216a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212193-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORALAB2025-04-21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212193-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORALAB2025-04-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A212193-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212193-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212193-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212193-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212193-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212193-002AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212193-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212193-002AB1a50c72e98297…

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.

Matched openFDA labels page 1 of 2 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Imatinib MesylateIMATINIB MESYLATEApotex Corp0291eca5-7a1d-4a79-30be-252224d965092026-07-28Warnings, Adverse reactionsName fallback
brand name: Imatinib Mesylate
generic name: IMATINIB MESYLATE
GleevecIMATINIB MESYLATENovartis Pharmaceuticals Corporation211ef2da-2868-4a77-8055-1cb2cd78e24b2026-07-13Warnings, Adverse reactionsName fallback
generic name: IMATINIB MESYLATE
IMATINIB MESYLATEIMATINIB MESYLATECivica Script LLC9fc5ec7b-98c4-4b1a-890c-be1343177dbd2026-07-03Warnings, Adverse reactionsName fallback
brand name: IMATINIB MESYLATE
generic name: IMATINIB MESYLATE
Imatinib MesylateIMATINIBGolden State Medical Supply, Inc.9131b2ce-752d-3a30-e053-2a95a90adaab2026-06-16Warnings, Adverse reactionsName fallback
brand name: Imatinib Mesylate
imatinib mesylateIMATINIB MESYLATESun Pharmaceutical Industries, Inc.07764bf9-21b4-4e32-9d7e-e348f8e4291f2026-06-01Warnings, Adverse reactionsName fallback
brand name: imatinib mesylate
generic name: IMATINIB MESYLATE
Imatinib MesylateIMATINIB MESYLATEBluePoint Laboratoriesc0611fc0-b217-4988-acd4-b8c629ce489b2026-05-21Warnings, Adverse reactionsName fallback
brand name: Imatinib Mesylate
generic name: IMATINIB MESYLATE
Imatinib MesylateIMATINIBMylan Pharmaceuticals Inc.a1787fad-3612-43e1-98fa-ce62361e0b3c2026-05-05Warnings, Adverse reactionsName fallback
brand name: Imatinib Mesylate
Imatinib MesylateIMATINIB MESYLATETeva Pharmaceuticals USA, Inc.a9cfc301-3c7f-4910-8813-41dcb0b4ca692026-04-29Warnings, Adverse reactionsName fallback
brand name: Imatinib Mesylate
generic name: IMATINIB MESYLATE
Imatinib MesylateIMATINIBSafecor Health, LLCf4acacbd-13f8-4a46-b615-b639a17f331f2026-04-17Warnings, Adverse reactionsName fallback
brand name: Imatinib Mesylate
Imatinib MesylateIMATINIB MESYLATEAurobindo Pharma Limiteda4e409f7-20b4-4c80-8a6a-f95995ffad782026-03-13Warnings, Adverse reactionsName fallback
brand name: Imatinib Mesylate
generic name: IMATINIB MESYLATE
Imatinib MesylateIMATINIB MESYLATEMajor Pharmaceuticals7c037022-7fc8-4b6e-9db3-427206c572b42026-02-13Warnings, Adverse reactionsName fallback
brand name: Imatinib Mesylate
generic name: IMATINIB MESYLATE
imatinib mesylateIMATINIB MESYLATEUpsher-Smith Laboratories, LLC5d07ac08-962e-41a8-8a3c-50febc8c5f342026-01-09Warnings, Adverse reactionsName fallback
brand name: imatinib mesylate
generic name: IMATINIB MESYLATE
Imatinib MesylateIMATINIB MESYLATEChartwell RX, LLC65b4d8a6-349d-4fb1-9818-dad6b4ad4fa12025-12-10Warnings, Adverse reactionsName fallback
brand name: Imatinib Mesylate
generic name: IMATINIB MESYLATE
IMATINIB MESYLATEIMATINIB MESYLATECamber Pharmaceuticals, Inc.e97f0238-b9da-46af-83a3-0826e39893e82025-11-25Warnings, Adverse reactionsName fallback
brand name: IMATINIB MESYLATE
generic name: IMATINIB MESYLATE
Imatinib MesylateIMATINIBMylan Institutional Inc1debf3a0-7587-47d7-8ea6-e739698d72972025-09-15Warnings, Adverse reactionsName fallback
brand name: Imatinib Mesylate
Imatinib MesylateIMATINIB MESYLATEAmerican Health Packaging6e7ed4ef-24e3-4545-9a99-2e34c946e8e72025-02-19Warnings, Adverse reactionsName fallback
brand name: Imatinib Mesylate
generic name: IMATINIB MESYLATE
imatinib mesylateIMATINIB MESYLATEQilu Pharmaceutical Co., Ltd.82eb01e0-8685-4f06-8a72-7663e8ded38f2024-12-04Warnings, Adverse reactionsName fallback
brand name: imatinib mesylate
generic name: IMATINIB MESYLATE
imatinib mesylateIMATINIB MESYLATEBluePoint Laboratoriesbe5b9047-155b-59ca-e053-2995a90ad3dc2023-09-21Warnings, Adverse reactionsName fallback
brand name: imatinib mesylate
generic name: IMATINIB MESYLATE
imatinib mesylateIMATINIB MESYLATEArchis Pharma LLC9de8d8b9-cf88-4960-82b7-89e5ceb7720e2023-09-21Warnings, Adverse reactionsName fallback
brand name: imatinib mesylate
generic name: IMATINIB MESYLATE
Imatinib MesylateIMATINIB MESYLATEQUALLENT PHARMACEUTICALS HEALTH LLCa819a954-41c9-4d49-a74e-c8c4b338b22a2023-09-16Warnings, Adverse reactionsName fallback
brand name: Imatinib Mesylate
generic name: IMATINIB MESYLATE