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

NDC Listings For This Application#

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