FDA.reportPublic FDA data

Application 077070

Type
ANDA
Sponsor
EPIC PHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SOTALOL HYDROCHLORIDESOTALOL HYDROCHLORIDETABLET;ORAL80MGNoNo
002SOTALOL HYDROCHLORIDESOTALOL HYDROCHLORIDETABLET;ORAL120MGNoNo
003SOTALOL HYDROCHLORIDESOTALOL HYDROCHLORIDETABLET;ORAL160MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42806-121Sotalol HydrochlorideSotalol HydrochlorideEpic Pharma, LLCANDACurrent
42806-121Sotalol HydrochlorideSotalol HydrochlorideEpic Pharma, LLCANDACurrent
42806-122Sotalol HydrochlorideSotalol HydrochlorideEpic Pharma, LLCANDACurrent
42806-122Sotalol HydrochlorideSotalol HydrochlorideEpic Pharma, LLCANDACurrent
42806-123Sotalol HydrochlorideSotalol HydrochlorideEpic Pharma, LLCANDACurrent
42806-123Sotalol HydrochlorideSotalol HydrochlorideEpic Pharma, LLCANDACurrent