FDA.reportPublic FDA data

Application 050285

Type
NDA
Sponsor
PHARMACIA AND UPJOHN

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N050285-001MYCIFRADINNEOMYCIN SULFATEEQ 87.5MG BASE/5MLSOLUTION / ORALApproved before 1982

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.

Product history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09N050285-001MYCIFRADINEQ 87.5MG BASE/5MLSOLUTION / ORALApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N050285-001MYCIFRADINEQ 87.5MG BASE/5MLSOLUTION / ORALApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N050285-001MYCIFRADINEQ 87.5MG BASE/5MLSOLUTION / ORALApproved before 1982a50c72e98297…

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 · 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.