FDA.reportPublic FDA data

Application 207818

Type
ANDA
Sponsor
NATCO PHARMA LTD

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
A207818-001IMATINIB MESYLATEIMATINIB MESYLATEEQ 100MG BASETABLET / ORALAB2019-03-01
A207818-002IMATINIB MESYLATEIMATINIB MESYLATEEQ 400MG BASETABLET / ORALAB2019-03-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207818-001AB
A207818-002AB

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
2026-08-01 22:54:322026-06A207818-001IMATINIB MESYLATEEQ 100MG BASETABLET / ORALAB2019-03-01a50c72e98297…
2026-08-01 22:54:322026-06A207818-002IMATINIB MESYLATEEQ 400MG BASETABLET / ORALAB2019-03-01a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A207818-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A207818-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68180-390IMATINIB MESYLATEIMATINIBLupin Pharmaceuticals, Inc.ANDACurrent
68180-390IMATINIB MESYLATEIMATINIBLupin Pharmaceuticals, Inc.ANDACurrent
68180-391IMATINIB MESYLATEIMATINIBLupin Pharmaceuticals, Inc.ANDACurrent
68180-391IMATINIB MESYLATEIMATINIBLupin Pharmaceuticals, Inc.ANDACurrent