FDA.reportPublic FDA data

Application 202220

Type
ANDA
Sponsor
EPIC PHARMA 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
42806-096Protriptyline HydrochlorideProtriptyline HydrochlorideEpic Pharma, LLCANDACurrent
42806-096Protriptyline HydrochlorideProtriptyline HydrochlorideEpic Pharma, LLCANDACurrent
42806-096Protriptyline HydrochlorideProtriptyline HydrochlorideEpic Pharma, LLCANDACurrent
42806-097Protriptyline HydrochlorideProtriptyline HydrochlorideEpic Pharma, LLCANDACurrent
42806-097Protriptyline HydrochlorideProtriptyline HydrochlorideEpic Pharma, LLCANDACurrent
42806-097Protriptyline HydrochlorideProtriptyline HydrochlorideEpic Pharma, LLCANDACurrent
50383-959Protriptyline hydrochlorideProtriptyline hydrochlorideHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-959Protriptyline hydrochlorideProtriptyline hydrochlorideHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-960Protriptyline hydrochlorideProtriptyline hydrochlorideHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-960Protriptyline hydrochlorideProtriptyline hydrochlorideHi-Tech Pharmacal Co., Inc.ANDACurrent