FDA.reportPublic FDA data

Application 214554

Type
ANDA
Sponsor
ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FOSFOMYCIN TROMETHAMINEFOSFOMYCIN TROMETHAMINEFOR SOLUTION;ORALEQ 3GM BASE/PACKETNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-6130Fosfomycin TromethamineFosfomycin TromethamineA-S Medication SolutionsANDACurrent
63629-9470Fosfomycin TromethamineFosfomycin TromethamineBryant Ranch PrepackANDACurrent
67877-749Fosfomycin TromethamineFosfomycin TromethamineAscend Laboratories, LLCANDACurrent
67877-749Fosfomycin TromethamineFosfomycin TromethamineAscend Laboratories, LLCANDACurrent