FDA.reportPublic FDA data

Application 065010

Type
ANDA
Sponsor
X GEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEO-FRADINNEOMYCIN SULFATESOLUTION;ORALEQ 87.5MG BASE/5MLNoNo

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065010-001NEO-FRADINNEOMYCIN SULFATEEQ 87.5MG BASE/5MLSOLUTION / ORAL2002-05-23

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

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

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings When handling this product ■ May cause skin & eye irritation; wear full PPE (gloves, goggles, respirator) ■ Avoid direct skin contact, inhalation of dust ■ Do not ingest; keep separate from food, drinks ■ Keep away from ignition sources, strong oxidizers ■ Restless/irritability may occur with improper exposure, especially for personnel without chemical handling training If pregnant/breastfeeding, consult industrial hygiene specialist before handling. Keep out of reach of children & untrained personnel. In case of accidental ingestion/skin absorption/eye contact, flush affected area with plenty of clean water and seek emergency medical help immediately.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18322SUPPL2012-07-30
42801ORIG2008-08-01
8368ORIG2003-04-09