FDA.reportPublic FDA data

Application 205536

Type
ANDA
Sponsor
ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VALSARTANVALSARTANTABLET;ORAL40MGNoNo
002VALSARTANVALSARTANTABLET;ORAL80MGNoNo
003VALSARTANVALSARTANTABLET;ORAL160MGNoNo
004VALSARTANVALSARTANTABLET;ORAL320MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-4293ValsartanValsartanA-S Medication SolutionsANDACurrent
50090-4294ValsartanValsartanA-S Medication SolutionsANDACurrent
50090-4295ValsartanValsartanA-S Medication SolutionsANDACurrent
60687-612ValsartanValsartanAmerican Health PackagingANDACurrent
60687-612ValsartanValsartanAmerican Health PackagingANDACurrent
60687-623ValsartanValsartanAmerican Health PackagingANDACurrent
60687-623ValsartanValsartanAmerican Health PackagingANDACurrent
60687-634ValsartanValsartanAmerican Health PackagingANDACurrent
60687-634ValsartanValsartanAmerican Health PackagingANDACurrent
67877-415ValsartanValsartanAscend Laboratories, LLCANDACurrent
67877-415ValsartanValsartanAscend Laboratories, LLCANDACurrent
67877-415ValsartanValsartanAscend Laboratories, LLCANDACurrent
67877-416ValsartanValsartanAscend Laboratories, LLCANDACurrent
67877-416ValsartanValsartanAscend Laboratories, LLCANDACurrent
67877-416ValsartanValsartanAscend Laboratories, LLCANDACurrent
67877-417ValsartanValsartanAscend Laboratories, LLCANDACurrent
67877-417ValsartanValsartanAscend Laboratories, LLCANDACurrent
67877-417ValsartanValsartanAscend Laboratories, LLCANDACurrent
67877-418ValsartanValsartanAscend Laboratories, LLCANDACurrent
67877-418ValsartanValsartanAscend Laboratories, LLCANDACurrent
67877-418ValsartanValsartanAscend Laboratories, LLCANDACurrent
71335-1337ValsartanValsartanBryant Ranch PrepackANDACurrent
71335-1337ValsartanValsartanBryant Ranch PrepackANDACurrent