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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

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

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
2026-08-01 22:54:322026-06A065010-001NEO-FRADINEQ 87.5MG BASE/5MLSOLUTION / ORAL2002-05-23a50c72e98297…

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. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 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

Documents#

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