FDA.reportPublic FDA data

Application 211009

Type
ANDA
Sponsor
ASCENT PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL18MGNoNo
002METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL27MGNoNo
003METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL36MGNoNo
004METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL54MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-124Methylphenidate HydrochlorideMethylphenidate HydrochlorideNorthstar Rx LLCANDACurrent
16714-124Methylphenidate HydrochlorideMethylphenidate HydrochlorideNorthstar Rx LLCANDACurrent
16714-125Methylphenidate HydrochlorideMethylphenidate HydrochlorideNorthstar Rx LLCANDACurrent
16714-125Methylphenidate HydrochlorideMethylphenidate HydrochlorideNorthstar Rx LLCANDACurrent
16714-126Methylphenidate HydrochlorideMethylphenidate HydrochlorideNorthstar Rx LLCANDACurrent
16714-126Methylphenidate HydrochlorideMethylphenidate HydrochlorideNorthstar Rx LLCANDACurrent
16714-127Methylphenidate HydrochlorideMethylphenidate HydrochlorideNorthstar Rx LLCANDACurrent
16714-127Methylphenidate HydrochlorideMethylphenidate HydrochlorideNorthstar Rx LLCANDACurrent
31722-952Methylphenidate HydrochlorideMethylphenidate HydrochlorideCamber Pharmaceuticals, Inc.ANDACurrent
31722-952Methylphenidate HydrochlorideMethylphenidate HydrochlorideCamber Pharmaceuticals IncANDACurrent
31722-953Methylphenidate HydrochlorideMethylphenidate HydrochlorideCamber Pharmaceuticals, Inc.ANDACurrent
31722-953Methylphenidate HydrochlorideMethylphenidate HydrochlorideCamber Pharmaceuticals IncANDACurrent
31722-954Methylphenidate HydrochlorideMethylphenidate HydrochlorideCamber Pharmaceuticals, Inc.ANDACurrent
31722-954Methylphenidate HydrochlorideMethylphenidate HydrochlorideCamber Pharmaceuticals IncANDACurrent
31722-955Methylphenidate HydrochlorideMethylphenidate HydrochlorideCamber Pharmaceuticals IncANDACurrent
31722-955Methylphenidate HydrochlorideMethylphenidate HydrochlorideCamber Pharmaceuticals, Inc.ANDACurrent
50268-545Methylphenidate HydrochlorideMethylphenidate HydrochlorideAvPAKANDACurrent
50268-545Methylphenidate HydrochlorideMethylphenidate HydrochlorideAvPAKANDACurrent
50268-546Methylphenidate HydrochlorideMethylphenidate HydrochlorideAvPAKANDACurrent
50268-546Methylphenidate HydrochlorideMethylphenidate HydrochlorideAvPAKANDACurrent
50268-547Methylphenidate HydrochlorideMethylphenidate HydrochlorideAvPAKANDACurrent
50268-547Methylphenidate HydrochlorideMethylphenidate HydrochlorideAvPAKANDACurrent
50268-548Methylphenidate HydrochlorideMethylphenidate HydrochlorideAvPAKANDACurrent
50268-548Methylphenidate HydrochlorideMethylphenidate HydrochlorideAvPAKANDACurrent
60687-532Methylphenidate HydrochlorideMethylphenidate HydrochlorideAmerican Health PackagingANDACurrent
60687-532Methylphenidate HydrochlorideMethylphenidate HydrochlorideAmerican Health PackagingANDACurrent
60687-532Methylphenidate HydrochlorideMethylphenidate HydrochlorideAmerican Health PackagingANDACurrent
60687-543Methylphenidate HydrochlorideMethylphenidate HydrochlorideAmerican Health PackagingANDACurrent
60687-543Methylphenidate HydrochlorideMethylphenidate HydrochlorideAmerican Health PackagingANDACurrent
60687-543Methylphenidate HydrochlorideMethylphenidate HydrochlorideAmerican Health PackagingANDACurrent
60687-554Methylphenidate HydrochlorideMethylphenidate HydrochlorideAmerican Health PackagingANDACurrent
60687-554Methylphenidate HydrochlorideMethylphenidate HydrochlorideAmerican Health PackagingANDACurrent
60687-554Methylphenidate HydrochlorideMethylphenidate HydrochlorideAmerican Health PackagingANDACurrent
60687-565Methylphenidate HydrochlorideMethylphenidate HydrochlorideAmerican Health PackagingANDACurrent
60687-565Methylphenidate HydrochlorideMethylphenidate HydrochlorideAmerican Health PackagingANDACurrent
60687-565Methylphenidate HydrochlorideMethylphenidate HydrochlorideAmerican Health PackagingANDACurrent
63629-1231Methylphenidate HydrochlorideMethylphenidate HydrochlorideBryant Ranch PrepackANDACurrent
63629-1231Methylphenidate HydrochlorideMethylphenidate HydrochlorideBryant Ranch PrepackANDACurrent
63629-1231Methylphenidate HydrochlorideMethylphenidate HydrochlorideBryant Ranch PrepackANDACurrent
63629-1902Methylphenidate HydrochlorideMethylphenidate HydrochlorideBryant Ranch PrepackANDACurrent
63629-1902Methylphenidate HydrochlorideMethylphenidate HydrochlorideBryant Ranch PrepackANDACurrent
63629-1902Methylphenidate HydrochlorideMethylphenidate HydrochlorideBryant Ranch PrepackANDACurrent
63629-1903Methylphenidate HydrochlorideMethylphenidate HydrochlorideBryant Ranch PrepackANDACurrent
63629-1903Methylphenidate HydrochlorideMethylphenidate HydrochlorideBryant Ranch PrepackANDACurrent
63629-1903Methylphenidate HydrochlorideMethylphenidate HydrochlorideBryant Ranch PrepackANDACurrent
63629-1904Methylphenidate HydrochlorideMethylphenidate HydrochlorideBryant Ranch PrepackANDACurrent
63629-1904Methylphenidate HydrochlorideMethylphenidate HydrochlorideBryant Ranch PrepackANDACurrent
63629-1904Methylphenidate HydrochlorideMethylphenidate HydrochlorideBryant Ranch PrepackANDACurrent
72865-133Methylphenidate HydrochlorideMethylphenidate HydrochlorideXLCare Pharmaceuticals IncANDACurrent
72865-133Methylphenidate HydrochlorideMethylphenidate HydrochlorideXLCare Pharmaceuticals, Inc.ANDACurrent
72865-134Methylphenidate HydrochlorideMethylphenidate HydrochlorideXLCare Pharmaceuticals IncANDACurrent
72865-134Methylphenidate HydrochlorideMethylphenidate HydrochlorideXLCare Pharmaceuticals, Inc.ANDACurrent
72865-135Methylphenidate HydrochlorideMethylphenidate HydrochlorideXLCare Pharmaceuticals IncANDACurrent
72865-135Methylphenidate HydrochlorideMethylphenidate HydrochlorideXLCare Pharmaceuticals, Inc.ANDACurrent
72865-136Methylphenidate HydrochlorideMethylphenidate HydrochlorideXLCare Pharmaceuticals IncANDACurrent
72865-136Methylphenidate HydrochlorideMethylphenidate HydrochlorideXLCare Pharmaceuticals, Inc.ANDACurrent