FDA.reportPublic FDA data

Application 210955

Type
ANDA
Sponsor
BEXIMCO PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NADOLOLNADOLOLTABLET;ORAL20MGNoNo
002NADOLOLNADOLOLTABLET;ORAL40MGNoNo
003NADOLOLNADOLOLTABLET;ORAL80MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10135-686NadololNadololMarlex Pharmaceuticals IncANDACurrent
10135-686NadololNadololMarlex Pharmaceuticals IncANDACurrent
10135-686NadololNadololMarlex Pharmaceuticals IncANDACurrent
10135-687NadololNadololMarlex Pharmaceuticals IncANDACurrent
10135-687NadololNadololMarlex Pharmaceuticals IncANDACurrent
10135-687NadololNadololMarlex Pharmaceuticals IncANDACurrent
10135-688NadololNadololMarlex Pharmaceuticals IncANDACurrent
10135-688NadololNadololMarlex Pharmaceuticals IncANDACurrent
10135-688NadololNadololMarlex Pharmaceuticals IncANDACurrent
71335-2131NadololNadololBryant Ranch PrepackANDACurrent
76385-133NadololNadololBayshore Pharmaceuticals LLCANDACurrent
76385-133NadololNadololBayshore Pharmaceuticals LLCANDACurrent
76385-134NadololNadololBayshore Pharmaceuticals LLCANDACurrent
76385-134NadololNadololBayshore Pharmaceuticals LLCANDACurrent
76385-135NadololNadololBayshore Pharmaceuticals LLCANDACurrent
76385-135NadololNadololBayshore Pharmaceuticals LLCANDACurrent