FDA.reportPublic FDA data

Application 209182

Type
ANDA
Sponsor
AM REGENT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEOSTIGMINE METHYLSULFATENEOSTIGMINE METHYLSULFATESOLUTION;INTRAVENOUS5MG/10ML (0.5MG/ML)NoNo
002NEOSTIGMINE METHYLSULFATENEOSTIGMINE METHYLSULFATESOLUTION;INTRAVENOUS10MG/10ML (1MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0517-1133Neostigmine MethylsulfateNeostigmine MethylsulfateAmerican Regent, Inc.ANDACurrent
0517-1133Neostigmine MethylsulfateNeostigmine MethylsulfateAmerican Regent, Inc.ANDACurrent
0517-1133Neostigmine MethylsulfateNeostigmine MethylsulfateAmerican Regent, Inc.ANDACurrent
0517-1134Neostigmine MethylsulfateNeostigmine MethylsulfateAmerican Regent, Inc.ANDACurrent
0517-1134Neostigmine MethylsulfateNeostigmine MethylsulfateAmerican Regent, Inc.ANDACurrent
0517-1134Neostigmine MethylsulfateNeostigmine MethylsulfateAmerican Regent, Inc.ANDACurrent