FDA.reportPublic FDA data

Application 212968

Type
ANDA
Sponsor
GLAND PHARMA LTD

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
50090-5197Neostigmine methylsulfateNeostigmine methylsulfateA-S Medication SolutionsANDACurrent
68083-383Neostigmine methylsulfateNeostigmine methylsulfateGland Pharma LimitedANDACurrent
68083-383Neostigmine methylsulfateNeostigmine methylsulfateGland Pharma LimitedANDACurrent
68083-384Neostigmine methylsulfateNeostigmine methylsulfateGland Pharma LimitedANDACurrent
68083-384Neostigmine methylsulfateNeostigmine methylsulfateGland Pharma LimitedANDACurrent
70700-171Neostigmine methylsulfateNeostigmine methylsulfateXiromed LLCANDACurrent
70700-171Neostigmine methylsulfateNeostigmine methylsulfateXiromed LLCANDACurrent
70700-172Neostigmine methylsulfateNeostigmine methylsulfateXiromed LLCANDACurrent
70700-172Neostigmine methylsulfateNeostigmine methylsulfateXiromed LLCANDACurrent