FDA.reportPublic FDA data

Application 078913

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROTRIPTYLINE HYDROCHLORIDEPROTRIPTYLINE HYDROCHLORIDETABLET;ORAL5MGNoNo
002PROTRIPTYLINE HYDROCHLORIDEPROTRIPTYLINE HYDROCHLORIDETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0210Protriptyline HydrochlorideProtriptyline HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0211Protriptyline HydrochlorideProtriptyline HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
63629-8346Protriptyline HydrochlorideProtriptyline HydrochlorideBryant Ranch PrepackANDACurrent
63629-8346Protriptyline HydrochlorideProtriptyline HydrochlorideBryant Ranch PrepackANDACurrent