FDA.reportPublic FDA data

Application 050717

Type
NDA
Sponsor
ZAMBON SPA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MONUROLFOSFOMYCIN TROMETHAMINEFOR SOLUTION;ORALEQ 3GM BASE/PACKETYesYes

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
N050717-001MONUROLFOSFOMYCIN TROMETHAMINEEQ 3GM BASE/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SOLUTION / ORALRLD1996-12-19

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 22:54:322026-06N050717-001MONUROLEQ 3GM BASE/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SOLUTION / ORALRLD1996-12-19a50c72e98297…

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fosfomycin TromethamineFOSFOMYCIN TROMETHAMINEAucta Pharmaceuticals, Inc.4f206750-8126-99a3-e063-6294a90ade4c2026-04-09Warnings, Adverse reactionsName fallback
generic name: FOSFOMYCIN TROMETHAMINE
Fosfomycin TromethamineFOSFOMYCIN TROMETHAMINEPrecision Dose, Inc.f44b79d0-a789-46cb-ab70-7eb33a7debaf2025-12-23Warnings, Adverse reactionsName fallback
generic name: FOSFOMYCIN TROMETHAMINE
Fosfomycin TromethamineFOSFOMYCIN TROMETHAMINEAscend Laboratories, LLC48e352bc-52ea-4778-905a-60ef38a5c18a2025-12-17Warnings, Adverse reactionsName fallback
generic name: FOSFOMYCIN TROMETHAMINE
Fosfomycin tromethamineFOSFOMYCIN TROMETHAMINEAurobindo Pharma Limitedf8ec4771-3f8d-473a-a1d0-e42038f61a422025-11-17Warnings, Adverse reactionsName fallback
generic name: FOSFOMYCIN TROMETHAMINE
Fosfomycin TromethamineFOSFOMYCIN TROMETHAMINEKesin Pharma Corporation3fa61bd4-fc55-0987-e063-6394a90abce22025-09-25Warnings, Adverse reactionsName fallback
generic name: FOSFOMYCIN TROMETHAMINE
FOSFOMYCIN TROMETHAMINEFOSFOMYCIN TROMETHAMINECipla USA Inc.d101b5d8-bffc-4ee6-b93b-4589fcb8750d2025-03-17Warnings, Adverse reactionsName fallback
generic name: FOSFOMYCIN TROMETHAMINE
Fosfomycin TromethamineFOSFOMYCIN TROMETHAMINEAmneal Pharmaceuticals NY LLCaacd04a4-f2d5-45a2-b9e7-0e92244a58802024-04-02Warnings, Adverse reactionsName fallback
generic name: FOSFOMYCIN TROMETHAMINE
Fosfomycin TromethamineFOSFOMYCIN TROMETHAMINEA-S Medication Solutions6b9167a9-80e9-44e1-a609-c3eb78960acf2023-11-01Warnings, Adverse reactionsName fallback
generic name: FOSFOMYCIN TROMETHAMINE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0456-4300MonurolFosfomycin tromethamineAllergan, Inc.NDACurrent
0456-4300MonurolFosfomycin tromethamineAllergan, Inc.NDACurrent
0456-4300MonurolFosfomycin tromethamineAllergan, Inc.NDACurrent
82036-4274Fosfomycin TromethamineFosfomycin TromethamineZambon USA, LtdNDA AUTHORIZED GENERICCurrent
82036-4274Fosfomycin TromethamineFosfomycin TromethamineZambon USA, LtdNDA AUTHORIZED GENERICCurrent
82036-4274Fosfomycin TromethamineFosfomycin TromethamineZambon USA, LtdNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56481SUPPL2018-11-23
56465SUPPL2018-11-15
54408SUPPL2018-06-01
54397SUPPL2018-05-31
8091SUPPL2011-04-13
18102SUPPL2011-04-11
30349SUPPL2008-03-13
18101SUPPL2008-03-13
39170SUPPL2003-04-07
30348SUPPL2002-12-18
57460ORIG1996-12-17