FDA.reportPublic FDA data

Application 208832

Type
ANDA
Sponsor
AMNEAL PHARMS CO

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
69238-1123NadololNadololAmneal Pharmaceuticals NY LLCANDACurrent
69238-1123NadololNadololAmneal Pharmaceuticals NY LLCANDACurrent
69238-1123NadololNadololAmneal Pharmaceuticals LLCANDACurrent
69238-1123NadololNadololAmneal Pharmaceuticals NY LLCANDACurrent
69238-1123NadololNadololAmneal Pharmaceuticals NY LLCANDACurrent
69238-1124NadololNadololAmneal Pharmaceuticals NY LLCANDACurrent
69238-1124NadololNadololAmneal Pharmaceuticals NY LLCANDACurrent
69238-1124NadololNadololAmneal Pharmaceuticals LLCANDACurrent
69238-1124NadololNadololAmneal Pharmaceuticals NY LLCANDACurrent
69238-1124NadololNadololAmneal Pharmaceuticals NY LLCANDACurrent
69238-1125NadololNadololAmneal Pharmaceuticals NY LLCANDACurrent
69238-1125NadololNadololAmneal Pharmaceuticals NY LLCANDACurrent
69238-1125NadololNadololAmneal Pharmaceuticals LLCANDACurrent
69238-1125NadololNadololAmneal Pharmaceuticals NY LLCANDACurrent
69238-1125NadololNadololAmneal Pharmaceuticals NY LLCANDACurrent