Application 210051

Type
ANDA
Sponsor
AMNEAL

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
70121-1478Neostigmine methylsulfateNeostigmine methylsulfateAmneal Pharmaceuticals LLCANDACurrent
70121-1478Neostigmine methylsulfateNeostigmine methylsulfateAmneal Pharmaceuticals LLCANDACurrent
70121-1478Neostigmine methylsulfateNeostigmine methylsulfateAmneal Biosciences LLCANDACurrent
70121-1478Neostigmine methylsulfateNeostigmine methylsulfateAmneal Pharmaceuticals LLCANDACurrent
70121-1478Neostigmine methylsulfateNeostigmine methylsulfateAmneal Pharmaceuticals LLCANDACurrent
70121-1479Neostigmine methylsulfateNeostigmine methylsulfateAmneal Pharmaceuticals LLCANDACurrent
70121-1479Neostigmine methylsulfateNeostigmine methylsulfateAmneal Pharmaceuticals LLCANDACurrent
70121-1479Neostigmine methylsulfateNeostigmine methylsulfateAmneal Biosciences LLCANDACurrent
70121-1479Neostigmine methylsulfateNeostigmine methylsulfateAmneal Pharmaceuticals LLCANDACurrent
70121-1479Neostigmine methylsulfateNeostigmine methylsulfateAmneal Pharmaceuticals LLCANDACurrent