FDA.reportPublic FDA data

Application 078796

Type
ANDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IRINOTECAN HYDROCHLORIDEIRINOTECAN HYDROCHLORIDEINJECTABLE;INJECTION500MG/25ML (20MG/ML)NoYes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078796-001IRINOTECAN HYDROCHLORIDEIRINOTECAN HYDROCHLORIDE500MG/25ML (20MG/ML)INJECTABLE / INJECTIONAPRS2008-02-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078796-001AP

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 22:54:322026-06A078796-001IRINOTECAN HYDROCHLORIDE500MG/25ML (20MG/ML)INJECTABLE / INJECTIONAPRS2008-02-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A078796-001AP1a50c72e98297…

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 1 · 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