FDA.reportPublic FDA data

Application 213412

Type
ANDA
Sponsor
ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHLORTHALIDONECHLORTHALIDONETABLET;ORAL25MGNoNo
002CHLORTHALIDONECHLORTHALIDONETABLET;ORAL50MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-5183ChlorthalidoneChlorthalidoneA-S Medication SolutionsANDACurrent
50090-6126ChlorthalidoneChlorthalidoneA-S Medication SolutionsANDACurrent
63629-8761ChlorthalidoneChlorthalidoneBryant Ranch PrepackANDACurrent
63629-8761ChlorthalidoneChlorthalidoneBryant Ranch PrepackANDACurrent
63629-8761ChlorthalidoneChlorthalidoneBryant Ranch PrepackANDACurrent
63629-8762ChlorthalidoneChlorthalidoneBryant Ranch PrepackANDACurrent
63629-8762ChlorthalidoneChlorthalidoneBryant Ranch PrepackANDACurrent
63629-8762ChlorthalidoneChlorthalidoneBryant Ranch PrepackANDACurrent
67877-696ChlorthalidoneChlorthalidoneAscend Laboratories, LLCANDACurrent
67877-696ChlorthalidoneChlorthalidoneAscend Laboratories, LLCANDACurrent
67877-697ChlorthalidoneChlorthalidoneAscend Laboratories, LLCANDACurrent
67877-697ChlorthalidoneChlorthalidoneAscend Laboratories, LLCANDACurrent
71335-2072ChlorthalidoneChlorthalidoneBryant Ranch PrepackANDACurrent
71335-2072ChlorthalidoneChlorthalidoneBryant Ranch PrepackANDACurrent