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 2 of 2 · 35 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FLUOROURACILFLUOROURACILEugia US LLC199ef964-8a9b-403e-a2ae-759280b3d1d12026-01-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOROURACIL
FluorouracilFLUOROURACILGland Pharma Limited572b710e-8e2b-46eb-bd80-648ad769d34d2025-11-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOROURACIL
FluorouracilFLUOROURACILGland Pharma Limitedea3497db-23b9-4ace-9a6f-b54853d04a822025-11-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FLUOROURACIL
FluorouracilFLUOROURACILProPharma Distribution43057fcd-1f87-cc1a-e063-6294a90a8d242025-11-07Warnings, Adverse reactionsName fallback
generic name: FLUOROURACIL
FluorouracilFLUOROURACILEncube Ethicals, Inc.2c631ce7-ea15-4b51-b5bc-4962e3c315cd2025-10-09Warnings, Adverse reactionsName fallback
generic name: FLUOROURACIL
FLUOROURACILFLUOROURACILEncube Ethicals, Inc.30294dd2-40fb-420d-b838-3763433088952025-09-09Warnings, Adverse reactionsName fallback
generic name: FLUOROURACIL
FluorouracilFLUOROURACILFresenius Kabi USA, LLCfdf2a165-2ca4-48be-89c1-570e6010b47c2025-06-11Warnings, Adverse reactionsName fallback
generic name: FLUOROURACIL
EfudexFLUOROURACILBausch Health US, LLC35de1c1c-bef5-46c5-b6f8-ea032147411c2025-04-23Name fallback
generic name: FLUOROURACIL
FluorouracilFLUOROURACILAccord Healthcare Inc.667d4059-de90-4d3f-86c2-c2573def2ecb2024-10-04Warnings, Adverse reactionsName fallback
generic name: FLUOROURACIL
FLUOROURACILFLUOROURACILDr. Reddy's Labratories Inc.e137c766-1f7f-0251-90b9-450c3d4d78b92024-04-01Warnings, Adverse reactionsName fallback
generic name: FLUOROURACIL
FluorouracilFLUOROURACILAlembic Pharmaceuticals Limitedb6b0d9e2-c6f0-4523-a33b-b958d32d3a282023-11-16Warnings, Adverse reactionsName fallback
generic name: FLUOROURACIL
FluorouracilFLUOROURACILAlembic Pharmaceuticals Limitedd10f12a2-7b38-4351-93df-1e8444d2a9e42023-05-10Warnings, Adverse reactionsName fallback
generic name: FLUOROURACIL
TOLAKFLUOROURACILHILL DERMACEUTICALS, INC.59de2709-00b8-4f0a-867c-f0dfeb9471922022-09-06Warnings, Adverse reactionsName fallback
generic name: FLUOROURACIL
FLUOROURACILFLUOROURACILMayne Pharma Inc.06475bd8-66d9-4f88-90e4-b367480dab392021-11-04Warnings, Adverse reactionsName fallback
generic name: FLUOROURACIL
FluorouracilFLUOROURACILMylan Pharmaceuticals Inc.744737c5-0d96-4214-82ab-6cff016b1ea02021-06-30Warnings, 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