FDA.reportPublic FDA data

Application 207429

Type
ANDA
Sponsor
BEXIMCO PHARMS USA

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
10135-715Sotalol HydrochlorideSotalol HydrochlorideMarlex Pharmaceuticals IncANDACurrent
10135-716Sotalol HydrochlorideSotalol HydrochlorideMarlex Pharmaceuticals IncANDACurrent
10135-717Sotalol HydrochlorideSotalol HydrochlorideMarlex Pharmaceuticals IncANDACurrent
76385-125Sotalol HydrochlorideSotalol Hydrochloride Tables AFBayshore Pharmaceuticals LLCANDACurrent
76385-126Sotalol HydrochlorideSotalol Hydrochloride Tables AFBayshore Pharmaceuticals LLCANDACurrent
76385-127Sotalol HydrochlorideSotalol Hydrochloride Tablets AFBayshore Pharmaceuticals LLCANDACurrent