FDA.reportPublic FDA data

Application 061579

Type
ANDA
Sponsor
X GEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEO-RXNEOMYCIN SULFATEPOWDER;FOR RX COMPOUNDING100%NoNo

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 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neomycin SulfateNEOMYCIN SULFATEShaanxi Shuvita Biotech Co., Ltd573e1fe7-4d9d-0a5f-e063-6394a90a85a82026-07-22WarningsName fallback
generic name: NEOMYCIN SULFATE
Neomycin SulfateNEOMYCIN SULFATEREMEDYREPACK INC.461f62b9-b9ec-43f2-aee7-0895638105b82026-04-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NEOMYCIN SULFATE
Neomycin SulfateNEOMYCIN SULFATEChartwell RX, LLC0aa6947b-4739-4b00-be93-7303a5fc687d2026-02-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NEOMYCIN SULFATE
Neomycin SulfateNEOMYCIN SULFATEAldermed Inc.4978bb06-8b7c-9a44-e063-6294a90ac4cf2026-02-12WarningsName fallback
generic name: NEOMYCIN SULFATE
VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTICNEOMYCIN SULFATECompania Internacional de Comercio, S.A.P.I de C.V.ba7a3331-466e-496f-bebd-9ee7067bcdb22025-11-19WarningsName fallback
generic name: NEOMYCIN SULFATE
POMADA SULFA FIRST AID ANTIBIOTICNEOMYCIN SULFATEGRANDALL DISTRIBUTING, LLC1d8e1fca-6864-7c08-e063-6394a90a08b62025-10-28WarningsName fallback
generic name: NEOMYCIN SULFATE
AntibioticNEOMYCIN SULFATETotal Resources International0725364b-b243-4891-af2f-a6049366d0382025-10-10WarningsName fallback
generic name: NEOMYCIN SULFATE
Neomycin SulfateNEOMYCIN SULFATESolaris Pharma Corporationf430c5d9-ae82-3314-e053-2a95a90af04c2025-10-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NEOMYCIN SULFATE
Pomada de SulfaNEOMYCIN SULFATEMenper Distributors, Inc.216f4d22-e5e8-46c8-a4ef-8d1532792b562025-07-22WarningsName fallback
generic name: NEOMYCIN SULFATE
First Aid Only Neomycin AntibioticNEOMYCIN SULFATEAcme United Corporationc651e98e-aabe-de46-e053-2a95a90a63072024-11-19WarningsName fallback
generic name: NEOMYCIN SULFATE
Single Antibiotic with NeomycinNEOMYCIN SULFATESafetec of Americae989cf7e-f3d1-42d2-af45-fc80095b97cb2024-02-08WarningsName fallback
generic name: NEOMYCIN SULFATE
Neomycin SulfateNEOMYCIN SULFATETeva Pharmaceuticals USA, Inc.777dbfab-f83e-4738-ae1e-78619a9f82a72022-10-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: NEOMYCIN SULFATE

Reported adverse events (FAERS/openFDA)#

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