FDA.reportPublic FDA data

Application 209271

Type
ANDA
Sponsor
INGENUS PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUOROURACILFLUOROURACILINJECTABLE;INJECTION500MG/10ML (50MG/ML)NoNo
002FLUOROURACILFLUOROURACILINJECTABLE;INJECTION2.5GM/50ML (50MG/ML)NoNo

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
A209271-001FLUOROURACILFLUOROURACIL5GM/100ML (50MG/ML)INJECTABLE / INJECTION2019-12-11
A209271-002FLUOROURACILFLUOROURACIL2.5GM/50ML (50MG/ML)INJECTABLE / INJECTION2019-12-11

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.

Product history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A209271-001FLUOROURACIL5GM/100ML (50MG/ML)INJECTABLE / INJECTION2019-12-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209271-002FLUOROURACIL2.5GM/50ML (50MG/ML)INJECTABLE / INJECTION2019-12-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209271-001FLUOROURACIL5GM/100ML (50MG/ML)INJECTABLE / INJECTION2019-12-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209271-002FLUOROURACIL2.5GM/50ML (50MG/ML)INJECTABLE / INJECTION2019-12-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209271-001FLUOROURACIL5GM/100ML (50MG/ML)INJECTABLE / INJECTION2019-12-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209271-002FLUOROURACIL2.5GM/50ML (50MG/ML)INJECTABLE / INJECTION2019-12-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209271-001FLUOROURACIL5GM/100ML (50MG/ML)INJECTABLE / INJECTION2019-12-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209271-002FLUOROURACIL2.5GM/50ML (50MG/ML)INJECTABLE / INJECTION2019-12-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209271-001FLUOROURACIL5GM/100ML (50MG/ML)INJECTABLE / INJECTION2019-12-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209271-002FLUOROURACIL2.5GM/50ML (50MG/ML)INJECTABLE / INJECTION2019-12-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209271-001FLUOROURACIL5GM/100ML (50MG/ML)INJECTABLE / INJECTION2019-12-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209271-002FLUOROURACIL2.5GM/50ML (50MG/ML)INJECTABLE / INJECTION2019-12-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209271-001FLUOROURACIL5GM/100ML (50MG/ML)INJECTABLE / INJECTION2019-12-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209271-002FLUOROURACIL2.5GM/50ML (50MG/ML)INJECTABLE / INJECTION2019-12-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209271-001FLUOROURACIL5GM/100ML (50MG/ML)INJECTABLE / INJECTION2019-12-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209271-002FLUOROURACIL2.5GM/50ML (50MG/ML)INJECTABLE / INJECTION2019-12-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209271-001FLUOROURACIL5GM/100ML (50MG/ML)INJECTABLE / INJECTION2019-12-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209271-002FLUOROURACIL2.5GM/50ML (50MG/ML)INJECTABLE / INJECTION2019-12-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209271-001FLUOROURACIL5GM/100ML (50MG/ML)INJECTABLE / INJECTION2019-12-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A209271-002FLUOROURACIL2.5GM/50ML (50MG/ML)INJECTABLE / INJECTION2019-12-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209271-001FLUOROURACIL5GM/100ML (50MG/ML)INJECTABLE / INJECTION2019-12-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209271-002FLUOROURACIL2.5GM/50ML (50MG/ML)INJECTABLE / INJECTION2019-12-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209271-001FLUOROURACIL5GM/100ML (50MG/ML)INJECTABLE / INJECTION2019-12-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209271-002FLUOROURACIL2.5GM/50ML (50MG/ML)INJECTABLE / INJECTION2019-12-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209271-001FLUOROURACIL5GM/100ML (50MG/ML)INJECTABLE / INJECTION2019-12-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209271-002FLUOROURACIL2.5GM/50ML (50MG/ML)INJECTABLE / INJECTION2019-12-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209271-001FLUOROURACIL5GM/100ML (50MG/ML)INJECTABLE / INJECTION2019-12-118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A209271-002FLUOROURACIL2.5GM/50ML (50MG/ML)INJECTABLE / INJECTION2019-12-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209271-001FLUOROURACIL5GM/100ML (50MG/ML)INJECTABLE / INJECTION2019-12-115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209271-002FLUOROURACIL2.5GM/50ML (50MG/ML)INJECTABLE / INJECTION2019-12-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209271-001FLUOROURACIL5GM/100ML (50MG/ML)INJECTABLE / INJECTION2019-12-115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A209271-002FLUOROURACIL2.5GM/50ML (50MG/ML)INJECTABLE / INJECTION2019-12-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209271-001FLUOROURACIL5GM/100ML (50MG/ML)INJECTABLE / INJECTION2019-12-114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A209271-002FLUOROURACIL2.5GM/50ML (50MG/ML)INJECTABLE / INJECTION2019-12-114b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A209271-001FLUOROURACIL5GM/100ML (50MG/ML)INJECTABLE / INJECTION2019-12-11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A209271-002FLUOROURACIL2.5GM/50ML (50MG/ML)INJECTABLE / INJECTION2019-12-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209271-001FLUOROURACIL5GM/100ML (50MG/ML)INJECTABLE / INJECTION2019-12-11782e0a99824c…
2021-12-28 21:50 UTC2021-12A209271-002FLUOROURACIL2.5GM/50ML (50MG/ML)INJECTABLE / INJECTION2019-12-11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209271-001FLUOROURACIL5GM/100ML (50MG/ML)INJECTABLE / INJECTION2019-12-1187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209271-002FLUOROURACIL2.5GM/50ML (50MG/ML)INJECTABLE / INJECTION2019-12-1187673890dc5c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-14 00:12 UTC2019-12A209271-001AP13f01610625f2…
2019-12-14 00:12 UTC2019-12A209271-002AP13f01610625f2…

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 · 39 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FAVLYXAFLUOROURACILAvyxa Pharma, LLC1daf714b-704c-4bcc-b6e0-6f0eb2bfe66b2026-07-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOROURACIL
FluorouracilFLUOROURACILSun Pharmaceutical Industries, Inc.1b2f6145-b338-42ed-88a7-f4da65c591642026-07-15Warnings, Adverse reactionsName fallback
brand name: Fluorouracil
generic name: FLUOROURACIL
FluorouracilFLUOROURACILFresenius Kabi USA, LLCbeb8c6c5-4b6e-4770-b6d4-718e33c7a2ff2026-07-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluorouracil
generic name: FLUOROURACIL
FluorouracilFLUOROURACILBluePoint Laboratoriesc612b05f-f37d-47fa-9c1e-b2d876dd70932026-07-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluorouracil
generic name: FLUOROURACIL
FluorouracilFLUOROURACILBluePoint Laboratoriescdf07a8b-91ee-424f-8c04-34f53dfb82be2026-07-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluorouracil
generic name: FLUOROURACIL
FluorouracilFLUOROURACILSun Pharmaceutical Industries, Inc.acca0036-f19c-459b-9dfc-9592f1cd588d2026-07-14Warnings, Adverse reactionsName fallback
brand name: Fluorouracil
generic name: FLUOROURACIL
FluorouracilFLUOROURACILNORTHSTAR RX LLC52ef5f41-2312-4b55-aa86-abd5bb28b9d32026-07-08Warnings, Adverse reactionsName fallback
brand name: Fluorouracil
generic name: FLUOROURACIL
FluorouracilFLUOROURACILFresenius Kabi USA, LLCb4328ae3-f48f-40b1-9719-1c1aced7c7342026-06-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluorouracil
generic name: FLUOROURACIL
FluorouracilFLUOROURACILFresenius Kabi USA, LLCa85ab26a-05ea-498f-8f34-564a925fa9d92026-06-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluorouracil
generic name: FLUOROURACIL
FluorouracilFLUOROURACILFresenius Kabi USA, LLC21af1777-87f7-4e40-9917-f1677e7ff1a52026-06-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluorouracil
generic name: FLUOROURACIL
FluorouracilFLUOROURACILMeitheal Pharmaceuticals Inc.de8a3fce-85a9-4a77-a3cd-e50179b930982026-04-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluorouracil
generic name: FLUOROURACIL
FluorouracilFLUOROURACILMeitheal Pharmaceuticals Inc.a0cd6301-c6e0-4b62-8683-39c99913db242026-04-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluorouracil
generic name: FLUOROURACIL
FluorouracilFLUOROURACILFresenius Kabi USA, LLCc45f5286-a52b-43e5-8a6f-d0312e7da0c82026-03-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluorouracil
generic name: FLUOROURACIL
FluorouracilFLUOROURACILBluePoint Laboratories300304fa-4791-4455-962c-493ae467f5042026-02-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluorouracil
generic name: FLUOROURACIL
FluorouracilFLUOROURACILBluePoint Laboratories9c42eeff-ab0c-4820-94d7-e1a3df9fda742026-02-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluorouracil
generic name: FLUOROURACIL
FluorouracilFLUOROURACILXiromed LLC19735014-c6fb-0a05-c330-2e9389c712162026-02-19Warnings, Adverse reactionsName fallback
brand name: Fluorouracil
generic name: FLUOROURACIL
FluorouracilFLUOROURACILXiromed LLCf4b0cae1-a2fc-2991-d663-3b729503cd1c2026-02-19Warnings, Adverse reactionsName fallback
brand name: Fluorouracil
generic name: FLUOROURACIL
FluorouracilFLUOROURACILAccord Healthcare, Inc.8eff167f-203a-4a81-b2fc-d8773bc3555e2026-02-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluorouracil
generic name: FLUOROURACIL
FluorouracilFLUOROURACILAccord Healthcare, Inc.66d451fe-2436-494c-80c5-4528c8e343692026-02-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluorouracil
generic name: FLUOROURACIL
fluorouracilFLUOROURACILSagent Pharmaceuticals37e35e8c-5d51-413b-a3a0-b72a18caaf652026-02-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: fluorouracil
generic name: FLUOROURACIL

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50742-482FLUOROURACILfluorouracilIngenus Pharmaceuticals, LLCANDACurrent
50742-482FLUOROURACILfluorouracilIngenus Pharmaceuticals, LLCANDACurrent
50742-482FLUOROURACILfluorouracilIngenus Pharmaceuticals, LLCANDACurrent
50742-483FLUOROURACILfluorouracilIngenus Pharmaceuticals, LLCANDACurrent
50742-483FLUOROURACILfluorouracilIngenus Pharmaceuticals, LLCANDACurrent
50742-483FLUOROURACILfluorouracilIngenus Pharmaceuticals, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85252SUPPL 2026-03-03
85234SUPPL 2026-03-03
77986SUPPL 2024-03-27
77975SUPPL 2024-03-26