FDA.reportPublic FDA data

Application 206402

Type
ANDA
Sponsor
ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GABAPENTINGABAPENTINTABLET;ORAL600MGNoNo
002GABAPENTINGABAPENTINTABLET;ORAL800MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-2539GabapentinGabapentinA-S Medication SolutionsANDACurrent
50090-2539GabapentinGabapentinA-S Medication SolutionsANDACurrent
50436-0428GabapentinGabapentinUnit Dose ServicesANDACurrent
50436-4290GabapentinGabapentinUnit Dose ServicesANDACurrent
63629-8060GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-8060GabapentinGabapentinBryant Ranch PrepackANDACurrent
67877-428GabapentinGabapentinAscend Laboratories, LLCANDACurrent
67877-428GabapentinGabapentinAscend Laboratories, LLCANDACurrent
67877-428GabapentinGabapentinAscend Laboratories, LLCANDACurrent
67877-428GabapentinGabapentinAscend Laboratories, LLCANDACurrent
67877-428GabapentinGabapentinAscend Laboratories, LLCANDACurrent
67877-428GabapentinGabapentinAscend Laboratories, LLCANDACurrent
67877-428GabapentinGabapentinAscend Laboratories, LLCANDACurrent
67877-429GabapentinGabapentinAscend Laboratories, LLCANDACurrent
67877-429GabapentinGabapentinAscend Laboratories, LLCANDACurrent
67877-429GabapentinGabapentinAscend Laboratories, LLCANDACurrent
67877-429GabapentinGabapentinAscend Laboratories, LLCANDACurrent
67877-429GabapentinGabapentinAscend Laboratories, LLCANDACurrent
67877-429GabapentinGabapentinAscend Laboratories, LLCANDACurrent
67877-429GabapentinGabapentinAscend Laboratories, LLCANDACurrent
70518-2842GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-2842GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-2842GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-2912GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70934-933GabapentinGabapentinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-950GabapentinGabapentinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-1200GabapentinGabapentinBryant Ranch PrepackANDACurrent
71335-1200GabapentinGabapentinBryant Ranch PrepackANDACurrent
71335-1200GabapentinGabapentinBryant Ranch PrepackANDACurrent
71335-1200GabapentinGabapentinBryant Ranch PrepackANDACurrent
71335-2037GabapentinGabapentinBryant Ranch PrepackANDACurrent
71335-2037GabapentinGabapentinBryant Ranch PrepackANDACurrent
71335-2038GabapentinGabapentinBryant Ranch PrepackANDACurrent
71335-2038GabapentinGabapentinBryant Ranch PrepackANDACurrent
71335-2048GabapentinGabapentinBryant Ranch PrepackANDACurrent
71335-2048GabapentinGabapentinBryant Ranch PrepackANDACurrent
71335-2048GabapentinGabapentinBryant Ranch PrepackANDACurrent
80425-0035NeurontinGabapentin 800mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0035GabapentinGabapentinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0035GabapentinGabapentinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent