FDA.reportPublic FDA data

Application 213074

Type
ANDA
Sponsor
CAPLIN

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
65145-111Neostigmine MethylsulfateNeostigmine MethylsulfateCaplin Steriles LimitedANDACurrent
65145-112Neostigmine MethylsulfateNeostigmine MethylsulfateCaplin Steriles LimitedANDACurrent
70069-805Neostigmine MethylsulfateNeostigmine MethylsulfateSomerset Therapeutics, LLCANDACurrent
70069-806Neostigmine MethylsulfateNeostigmine MethylsulfateSomerset Therapeutics, LLCANDACurrent
70594-069Neostigmine MethylsulfateNeostigmine MethylsulfateXellia Pharmaceuticals USA LLCANDACurrent
70594-072Neostigmine MethylsulfateNeostigmine MethylsulfateXellia Pharmaceuticals USA LLCANDACurrent
71872-7271Neostigmine MethylsulfateNeostigmine MethylsulfateMedical Purchasing Solutions, LLCANDACurrent