FDA.reportPublic FDA data

Application 077260

Type
ANDA
Sponsor
TEVA PARENTERAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IRINOTECAN HYDROCHLORIDEIRINOTECAN HYDROCHLORIDEINJECTABLE; INJECTION40MG/2ML (20MG/ML)NoNo
002IRINOTECAN HYDROCHLORIDEIRINOTECAN HYDROCHLORIDEINJECTABLE; INJECTION100MG/5ML (20MG/ML)NoNo

Source provenance: Browse the complete Orange Book source catalog.

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 1 ยท 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CamptosarIRINOTECAN HYDROCHLORIDEPharmacia & Upjohn Company LLCe518dfc6-7e93-4fee-a66c-51e1ab71c0562026-05-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: IRINOTECAN HYDROCHLORIDE
Irinotecan HydrochlorideIRINOTECAN HYDROCHLORIDEIngenus Pharmaceuticals, LLCd04f2471-3085-4fc8-a657-bb3918d48e6e2026-03-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Irinotecan Hydrochloride
generic name: IRINOTECAN HYDROCHLORIDE
Irinotecan hydrochloideIRINOTECAN HYDROCHLOIDEXiromed LLCb26e5d27-dba5-7538-9e7b-48b358998cbb2026-02-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Irinotecan hydrochloride
generic name: IRINOTECAN HYDROCHLORIDE
Irinotecan HydrochlorideIRINOTECAN HYDROCHLORIDESagent Pharmaceuticalscaab50e6-0dad-4ddd-9a6c-96cc2b87aee72026-02-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Irinotecan Hydrochloride
generic name: IRINOTECAN HYDROCHLORIDE
Irinotecan HydrochlorideIRINOTECAN HYDROCHLORIDEHospira, Inc.5c527c2e-9062-4afe-dbbb-f650db3a340f2025-11-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Irinotecan Hydrochloride
generic name: IRINOTECAN HYDROCHLORIDE
IRINOTECAN HYDROCHLORIDEIRINOTECAN HYDROCHLORIDEEugia US LLC7a30d551-9ea7-47ea-9073-f541bff457a32025-06-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: IRINOTECAN HYDROCHLORIDE
generic name: IRINOTECAN HYDROCHLORIDE
Irinotecan hydrochlorideIRINOTECAN HYDROCHLORIDEActavis Pharma, Inc.5e1fdcaa-918f-4cd8-9c7a-4c538d8661982025-05-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Irinotecan hydrochloride
generic name: IRINOTECAN HYDROCHLORIDE
OnivydeIRINOTECAN HYDROCHLORIDEIpsen Biopharmaceuticals, Inc.c8b58efa-1820-48a4-b70d-62918fc4abfc2025-03-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: IRINOTECAN HYDROCHLORIDE
Irinotecan HydrochlorideIRINOTECAN HYDROCHLORIDEApotex Corp.8fe98987-e526-4729-a8f4-c7230f4241082024-07-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Irinotecan Hydrochloride
generic name: IRINOTECAN HYDROCHLORIDE
Irinotecan HydrochlorideIRINOTECAN HYDROCHLORIDEApotex Corp.85ed6019-f462-4abe-a89e-ad991623c86d2024-06-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Irinotecan Hydrochloride
generic name: IRINOTECAN HYDROCHLORIDE
Irinotecan HydrochlorideIRINOTECAN HYDROCHLORIDEFresenius Kabi USA, LLCee45f127-8450-4455-a945-a1f5707f1d392023-01-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Irinotecan Hydrochloride
generic name: IRINOTECAN HYDROCHLORIDE
Irinotecan hydrochlorideIRINOTECAN HYDROCHLORIDENorthstar Rx LLC4f98e9ed-f7b1-5346-af72-fccb0abf3f4b2022-03-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Irinotecan hydrochloride
generic name: IRINOTECAN HYDROCHLORIDE
Irinotecan hydrochloideIRINOTECAN HYDROCHLOIDEGland Pharma Limitedde634e80-328a-4473-b395-0172683a24112022-03-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Irinotecan hydrochloride
generic name: IRINOTECAN HYDROCHLORIDE
Irinotecan HydrochlorideIRINOTECAN HYDROCHLORIDEQilu Pharmaceutical Co., Ltd.afcdde49-ec0c-4c56-a1af-2917185b1a082021-03-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Irinotecan Hydrochloride
generic name: IRINOTECAN HYDROCHLORIDE
Irinotecan HydrochlorideIRINOTECAN HYDROCHLORIDEHikma Pharmaceuticals USA Inc.9c6aa884-750e-4b11-9955-bc7ab6e9c2ad2020-06-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Irinotecan Hydrochloride
generic name: IRINOTECAN HYDROCHLORIDE
Irinotecan HydrochlorideIRINOTECAN HYDROCHLORIDEHikma Pharmaceuticals USA Inc.be716692-6b4f-47b6-83d1-01665861626b2020-06-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Irinotecan Hydrochloride
generic name: IRINOTECAN HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.