FDA.reportPublic FDA data

Application 089368

Type
ANDA
Sponsor
QUAD PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUOROURACILFLUOROURACILInjectable; Injection50MG/MLNoNo

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 2 of 2 · 36 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
brand name: FLUOROURACIL
generic name: FLUOROURACIL
FluorouracilFLUOROURACILGland Pharma Limited572b710e-8e2b-46eb-bd80-648ad769d34d2025-11-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluorouracil
generic name: FLUOROURACIL
FluorouracilFLUOROURACILGland Pharma Limitedea3497db-23b9-4ace-9a6f-b54853d04a822025-11-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluorouracil
generic name: FLUOROURACIL
FluorouracilFLUOROURACILProPharma Distribution43057fcd-1f87-cc1a-e063-6294a90a8d242025-11-07Warnings, Adverse reactionsName fallback
brand name: Fluorouracil
generic name: FLUOROURACIL
FluorouracilFLUOROURACILEncube Ethicals, Inc.2c631ce7-ea15-4b51-b5bc-4962e3c315cd2025-10-09Warnings, Adverse reactionsName fallback
brand name: Fluorouracil
generic name: FLUOROURACIL
FLUOROURACILFLUOROURACILEncube Ethicals, Inc.30294dd2-40fb-420d-b838-3763433088952025-09-09Warnings, Adverse reactionsName fallback
brand name: FLUOROURACIL
generic name: FLUOROURACIL
FLUOROURACILFLUOROURACIL CREAM, 0.5%Dr. Reddy's Laboratories Inc.37dcfb83-0e7d-d23d-9cd5-afa5bdc306282025-07-11Warnings, Adverse reactionsName fallback
brand name: FLUOROURACIL
FluorouracilFLUOROURACILFresenius Kabi USA, LLCfdf2a165-2ca4-48be-89c1-570e6010b47c2025-06-11Warnings, Adverse reactionsName fallback
brand name: Fluorouracil
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
brand name: Fluorouracil
generic name: FLUOROURACIL
FLUOROURACILFLUOROURACILDr. Reddy's Labratories Inc.e137c766-1f7f-0251-90b9-450c3d4d78b92024-04-01Warnings, Adverse reactionsName fallback
brand name: FLUOROURACIL
generic name: FLUOROURACIL
FluorouracilFLUOROURACILAlembic Pharmaceuticals Limitedb6b0d9e2-c6f0-4523-a33b-b958d32d3a282023-11-16Warnings, Adverse reactionsName fallback
brand name: Fluorouracil
generic name: FLUOROURACIL
FluorouracilFLUOROURACILAlembic Pharmaceuticals Limitedd10f12a2-7b38-4351-93df-1e8444d2a9e42023-05-10Warnings, Adverse reactionsName fallback
brand name: Fluorouracil
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
brand name: FLUOROURACIL
generic name: FLUOROURACIL
FluorouracilFLUOROURACILMylan Pharmaceuticals Inc.744737c5-0d96-4214-82ab-6cff016b1ea02021-06-30Warnings, Adverse reactionsName fallback
brand name: Fluorouracil
generic name: FLUOROURACIL

Reported adverse events (FAERS/openFDA)#

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