FDA.reportPublic FDA data

Application 211891

Type
ANDA
Sponsor
ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOLVAPTANTOLVAPTANTABLET;ORAL30MGNoNo
002TOLVAPTANTOLVAPTANTABLET;ORAL60MGNoNo
003TOLVAPTANTOLVAPTANTABLET;ORAL15MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67877-635TolvaptanTolvaptanAscend Laboratories, LLCANDACurrent
67877-636TolvaptanTolvaptanAscend Laboratories, LLCANDACurrent
67877-636TolvaptanTolvaptanAscend Laboratories, LLCANDACurrent
67877-636TolvaptanTolvaptanAscend Laboratories, LLCANDACurrent
67877-636TolvaptanTolvaptanAscend Laboratories, LLCANDACurrent
67877-637TolvaptanTolvaptanAscend Laboratories, LLCANDACurrent
67877-637TolvaptanTolvaptanAscend Laboratories, LLCANDACurrent
67877-637TolvaptanTolvaptanAscend Laboratories, LLCANDACurrent
67877-637TolvaptanTolvaptanAscend Laboratories, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62171ORIG2020-03-17