FDA.reportPublic FDA data

Application 207485

Type
ANDA
Sponsor
ABHAI LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDESOLUTION;ORAL5MG/5MLNoNo
002METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDESOLUTION;ORAL10MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10702-163MethylphenidateMethylphenidate HydrochlorideKVK-Tech, Inc.ANDACurrent
10702-164MethylphenidateMethylphenidate HydrochlorideKVK-Tech, Inc.ANDACurrent