FDA.reportPublic FDA data

Application 220201

Type
NDA
Sponsor
AVYXA HOLDINGS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FAVLYXAFLUOROURACILSOLUTION;INTRAVENOUS250MG/10ML (25MG/ML)YesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N220201-001FAVLYXAFLUOROURACIL250MG/10ML (25MG/ML)SOLUTION / INTRAVENOUSRLD, RS2026-02-20
N220201-002FAVLYXAFLUOROURACIL2.5GM/100ML (25MG/ML)SOLUTION / INTRAVENOUSRLD, RS2026-07-06

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
2026-09-14 22:38:342026-08N220201-001FAVLYXA250MG/10ML (25MG/ML)SOLUTION / INTRAVENOUSRLD, RS2026-02-2084e616aacf4f…
2026-09-14 22:38:342026-08N220201-002FAVLYXA2.5GM/100ML (25MG/ML)SOLUTION / INTRAVENOUSRLD, RS2026-07-0684e616aacf4f…
2026-08-18 06:07:402026-07N220201-001FAVLYXA250MG/10ML (25MG/ML)SOLUTION / INTRAVENOUSRLD, RS2026-02-20caaa826d4ba7…
2026-08-18 06:07:402026-07N220201-002FAVLYXA2.5GM/100ML (25MG/ML)SOLUTION / INTRAVENOUSRLD, RS2026-07-06caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220201-001FAVLYXA250MG/10ML (25MG/ML)SOLUTION / INTRAVENOUSRLD, RS2026-02-20a50c72e98297…

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 · 35 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FLUOROURACILFLUOROURACILHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.f0b60247-89ff-42b5-a55b-61980c2827492026-08-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOROURACIL
FluorouracilFLUOROURACILSun Pharmaceutical Industries, Inc.1b2f6145-b338-42ed-88a7-f4da65c591642026-07-15Warnings, Adverse reactionsName fallback
generic name: FLUOROURACIL
FluorouracilFLUOROURACILFresenius Kabi USA, LLCbeb8c6c5-4b6e-4770-b6d4-718e33c7a2ff2026-07-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOROURACIL
FluorouracilFLUOROURACILBluePoint Laboratoriesc612b05f-f37d-47fa-9c1e-b2d876dd70932026-07-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOROURACIL
FluorouracilFLUOROURACILBluePoint Laboratoriescdf07a8b-91ee-424f-8c04-34f53dfb82be2026-07-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOROURACIL
FluorouracilFLUOROURACILSun Pharmaceutical Industries, Inc.acca0036-f19c-459b-9dfc-9592f1cd588d2026-07-14Warnings, Adverse reactionsName fallback
generic name: FLUOROURACIL
FluorouracilFLUOROURACILNORTHSTAR RX LLC52ef5f41-2312-4b55-aa86-abd5bb28b9d32026-07-08Warnings, Adverse reactionsName fallback
generic name: FLUOROURACIL
FluorouracilFLUOROURACILFresenius Kabi USA, LLCb4328ae3-f48f-40b1-9719-1c1aced7c7342026-06-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOROURACIL
FluorouracilFLUOROURACILFresenius Kabi USA, LLCa85ab26a-05ea-498f-8f34-564a925fa9d92026-06-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOROURACIL
FluorouracilFLUOROURACILFresenius Kabi USA, LLC21af1777-87f7-4e40-9917-f1677e7ff1a52026-06-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOROURACIL
FLUOROURACILFLUOROURACILHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.b268684b-487f-4716-a2e8-6e6d3e117b142026-06-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOROURACIL
FluorouracilFLUOROURACILMeitheal Pharmaceuticals Inc.de8a3fce-85a9-4a77-a3cd-e50179b930982026-04-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOROURACIL
FluorouracilFLUOROURACILMeitheal Pharmaceuticals Inc.a0cd6301-c6e0-4b62-8683-39c99913db242026-04-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOROURACIL
FluorouracilFLUOROURACILFresenius Kabi USA, LLCc45f5286-a52b-43e5-8a6f-d0312e7da0c82026-03-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOROURACIL
FluorouracilFLUOROURACILXiromed LLC19735014-c6fb-0a05-c330-2e9389c712162026-02-19Warnings, Adverse reactionsName fallback
generic name: FLUOROURACIL
FluorouracilFLUOROURACILXiromed LLCf4b0cae1-a2fc-2991-d663-3b729503cd1c2026-02-19Warnings, Adverse reactionsName fallback
generic name: FLUOROURACIL
FluorouracilFLUOROURACILAccord Healthcare, Inc.8eff167f-203a-4a81-b2fc-d8773bc3555e2026-02-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOROURACIL
FluorouracilFLUOROURACILAccord Healthcare, Inc.66d451fe-2436-494c-80c5-4528c8e343692026-02-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOROURACIL
fluorouracilFLUOROURACILSagent Pharmaceuticals37e35e8c-5d51-413b-a3a0-b72a18caaf652026-02-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOROURACIL
FLUOROURACILFLUOROURACILEugia US LLC697816ce-dc05-4943-b7f0-2f0b125e93b72026-01-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOROURACIL

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85156ORIG 2026-02-25
85113ORIG 2026-02-24