FDA.reportPublic FDA data

Application 213911

Type
ANDA
Sponsor
ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DROXIDOPADROXIDOPACAPSULE;ORAL100MGNoNo
002DROXIDOPADROXIDOPACAPSULE;ORAL200MGNoNo
003DROXIDOPADROXIDOPACAPSULE;ORAL300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67877-704DroxidopaDroxidopaAscend Laboratories, LLCANDACurrent
67877-704DroxidopaDroxidopaAscend Laboratories, LLCANDACurrent
67877-705DroxidopaDroxidopaAscend Laboratories, LLCANDACurrent
67877-705DroxidopaDroxidopaAscend Laboratories, LLCANDACurrent
67877-706DroxidopaDroxidopaAscend Laboratories, LLCANDACurrent
67877-706DroxidopaDroxidopaAscend Laboratories, LLCANDACurrent