Application 071055

Type
ANDA
Sponsor
QUAD PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLOXURIDINEFLOXURIDINEInjectable; Injection500MG/VIALNoNo

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 1 of 1 ยท 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FloxuridineFLOXURIDINEFresenius Kabi USA, LLCc8edabc1-67cd-421b-a147-7c1f19f05b8e2024-10-14Warnings, Adverse reactionsName fallback
brand name: Floxuridine
generic name: FLOXURIDINE
FloxuridineFLOXURIDINEJND Therapeutics, Inc.4681f23e-6b5e-433b-b245-3d0b4e64ebb22024-10-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Floxuridine
generic name: FLOXURIDINE
FloxuridineFLOXURIDINEHikma Pharmaceuticals USA Inc.e3c2e3e7-bc83-465d-b615-3ad56580b3a72023-05-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Floxuridine
generic name: FLOXURIDINE

Reported adverse events (FAERS/openFDA)#

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