FDA.reportPublic FDA data

Application 090462

Type
ANDA
Sponsor
SIGMAPHARM LABS LLC

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
42794-004Protriptyline HydrochlorideProtriptyline HydrochlorideSigmapharm Laboratories, LLCANDACurrent
42794-004Protriptyline HydrochlorideProtriptyline HydrochlorideSigmapharm Laboratories, LLCANDACurrent
42794-007Protriptyline HydrochlorideProtriptyline HydrochlorideSigmapharm Laboratories, LLCANDACurrent
42794-007Protriptyline HydrochlorideProtriptyline HydrochlorideSigmapharm Laboratories, LLCANDACurrent
64980-158Protriptyline HydrochlorideProtriptyline HydrochlorideRising Pharmaceuticals, IncANDACurrent
64980-158Protriptyline HydrochlorideProtriptyline HydrochlorideRising Pharmaceuticals, IncANDACurrent
64980-159Protriptyline HydrochlorideProtriptyline HydrochlorideRising Pharmaceuticals, IncANDACurrent
64980-159Protriptyline HydrochlorideProtriptyline HydrochlorideRising Pharmaceuticals, IncANDACurrent