FDA.reportPublic FDA data

Application 210354

Type
ANDA
Sponsor
ASCENT PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDETABLET, CHEWABLE;ORAL2.5MGNoNo
002METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDETABLET, CHEWABLE;ORAL5MGNoNo
003METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDETABLET, CHEWABLE;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
31722-926Methylphenidate HydrochlorideMethylphenidate HydrochlorideCamber Pharmaceuticals IncANDACurrent
31722-926Methylphenidate HydrochlorideMethylphenidate HydrochlorideCamber Pharmaceuticals IncANDACurrent
31722-926Methylphenidate HydrochlorideMethylphenidate HydrochlorideCamber Pharmaceuticals IncANDACurrent
31722-927Methylphenidate HydrochlorideMethylphenidate HydrochlorideCamber Pharmaceuticals IncANDACurrent
31722-927Methylphenidate HydrochlorideMethylphenidate HydrochlorideCamber Pharmaceuticals IncANDACurrent
31722-927Methylphenidate HydrochlorideMethylphenidate HydrochlorideCamber Pharmaceuticals IncANDACurrent
31722-928Methylphenidate HydrochlorideMethylphenidate HydrochlorideCamber Pharmaceuticals IncANDACurrent
31722-928Methylphenidate HydrochlorideMethylphenidate HydrochlorideCamber Pharmaceuticals IncANDACurrent
31722-928Methylphenidate HydrochlorideMethylphenidate HydrochlorideCamber Pharmaceuticals IncANDACurrent
63629-1919Methylphenidate HydrochlorideMethylphenidate HydrochlorideBryant Ranch PrepackANDACurrent
63629-1919Methylphenidate HydrochlorideMethylphenidate HydrochlorideBryant Ranch PrepackANDACurrent
63629-1919Methylphenidate HydrochlorideMethylphenidate HydrochlorideBryant Ranch PrepackANDACurrent
63629-1921Methylphenidate HydrochlorideMethylphenidate HydrochlorideBryant Ranch PrepackANDACurrent
63629-1921Methylphenidate HydrochlorideMethylphenidate HydrochlorideBryant Ranch PrepackANDACurrent
63629-1921Methylphenidate HydrochlorideMethylphenidate HydrochlorideBryant Ranch PrepackANDACurrent
63629-1923Methylphenidate HydrochlorideMethylphenidate HydrochlorideBryant Ranch PrepackANDACurrent
63629-1923Methylphenidate HydrochlorideMethylphenidate HydrochlorideBryant Ranch PrepackANDACurrent
63629-1923Methylphenidate HydrochlorideMethylphenidate HydrochlorideBryant Ranch PrepackANDACurrent
72865-125Methylphenidate HydrochlorideMethylphenidate HydrochlorideXLCare Pharmaceuticals, IncANDACurrent
72865-125Methylphenidate HydrochlorideMethylphenidate HydrochlorideXLCare Pharmaceuticals, IncANDACurrent
72865-125Methylphenidate HydrochlorideMethylphenidate HydrochlorideXLCare Pharmaceuticals, IncANDACurrent
72865-126Methylphenidate HydrochlorideMethylphenidate HydrochlorideXLCare Pharmaceuticals, IncANDACurrent
72865-126Methylphenidate HydrochlorideMethylphenidate HydrochlorideXLCare Pharmaceuticals, IncANDACurrent
72865-126Methylphenidate HydrochlorideMethylphenidate HydrochlorideXLCare Pharmaceuticals, IncANDACurrent
72865-127Methylphenidate HydrochlorideMethylphenidate HydrochlorideXLCare Pharmaceuticals, IncANDACurrent
72865-127Methylphenidate HydrochlorideMethylphenidate HydrochlorideXLCare Pharmaceuticals, IncANDACurrent
72865-127Methylphenidate HydrochlorideMethylphenidate HydrochlorideXLCare Pharmaceuticals, IncANDACurrent