FDA.reportPublic FDA data

Application 208687

Type
ANDA
Sponsor
ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AZATHIOPRINEAZATHIOPRINETABLET;ORAL25MGNoNo
002AZATHIOPRINEAZATHIOPRINETABLET;ORAL50MGNoNo
003AZATHIOPRINEAZATHIOPRINETABLET;ORAL75MGNoNo
004AZATHIOPRINEAZATHIOPRINETABLET;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67877-492AzathioprineAzathioprineAscend Laboratories, LLCANDACurrent
67877-492AzathioprineAzathioprineAscend Laboratories, LLCANDACurrent
67877-493AzathioprineAzathioprineAscend Laboratories, LLCANDACurrent
67877-493AzathioprineAzathioprineAscend Laboratories, LLCANDACurrent
67877-494AzathioprineAzathioprineAscend Laboratories, LLCANDACurrent
67877-494AzathioprineAzathioprineAscend Laboratories, LLCANDACurrent
67877-495AzathioprineAzathioprineAscend Laboratories, LLCANDACurrent
67877-495AzathioprineAzathioprineAscend Laboratories, LLCANDACurrent
70518-3544AzathioprineAzathioprineREMEDYREPACK INC.ANDACurrent