FDA.reportPublic FDA data

Application 209222

Type
ANDA
Sponsor
ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATINTABLET;ORAL10MG;10MGNoNo
002EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATINTABLET;ORAL10MG;20MGNoNo
003EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATINTABLET;ORAL10MG;40MGNoNo
004EZETIMIBE AND SIMVASTATINEZETIMIBE; SIMVASTATINTABLET;ORAL10MG;80MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-4772Ezetimibe and SimvastatinEzetimibe and SimvastatinA-S Medication SolutionsANDACurrent
50090-4772Ezetimibe and SimvastatinEzetimibe and SimvastatinA-S Medication SolutionsANDACurrent
67877-507Ezetimibe and SimvastatinEzetimibe and SimvastatinAscend Laboratories, LLCANDACurrent
67877-507Ezetimibe and SimvastatinEzetimibe and SimvastatinAscend Laboratories, LLCANDACurrent
67877-507Ezetimibe and SimvastatinEzetimibe and SimvastatinAscend Laboratories, LLCANDACurrent
67877-507Ezetimibe and SimvastatinEzetimibe and SimvastatinAscend Laboratories, LLCANDACurrent
67877-507Ezetimibe and SimvastatinEzetimibe and SimvastatinAscend Laboratories, LLCANDACurrent
67877-508Ezetimibe and SimvastatinEzetimibe and SimvastatinAscend Laboratories, LLCANDACurrent
67877-508Ezetimibe and SimvastatinEzetimibe and SimvastatinAscend Laboratories, LLCANDACurrent
67877-508Ezetimibe and SimvastatinEzetimibe and SimvastatinAscend Laboratories, LLCANDACurrent
67877-508Ezetimibe and SimvastatinEzetimibe and SimvastatinAscend Laboratories, LLCANDACurrent
67877-508Ezetimibe and SimvastatinEzetimibe and SimvastatinAscend Laboratories, LLCANDACurrent
67877-509Ezetimibe and SimvastatinEzetimibe and SimvastatinAscend Laboratories, LLCANDACurrent
67877-509Ezetimibe and SimvastatinEzetimibe and SimvastatinAscend Laboratories, LLCANDACurrent
67877-509Ezetimibe and SimvastatinEzetimibe and SimvastatinAscend Laboratories, LLCANDACurrent
67877-509Ezetimibe and SimvastatinEzetimibe and SimvastatinAscend Laboratories, LLCANDACurrent
67877-509Ezetimibe and SimvastatinEzetimibe and SimvastatinAscend Laboratories, LLCANDACurrent
67877-510Ezetimibe and SimvastatinEzetimibe and SimvastatinAscend Laboratories, LLCANDACurrent
67877-510Ezetimibe and SimvastatinEzetimibe and SimvastatinAscend Laboratories, LLCANDACurrent
67877-510Ezetimibe and SimvastatinEzetimibe and SimvastatinAscend Laboratories, LLCANDACurrent
67877-510Ezetimibe and SimvastatinEzetimibe and SimvastatinAscend Laboratories, LLCANDACurrent
67877-510Ezetimibe and SimvastatinEzetimibe and SimvastatinAscend Laboratories, LLCANDACurrent
70518-1850Ezetimibe and SimvastatinEzetimibe and SimvastatinREMEDYREPACK INC.ANDACurrent
70518-1955Ezetimibe and SimvastatinEzetimibe and SimvastatinREMEDYREPACK INC.ANDACurrent
70518-1955Ezetimibe and SimvastatinEzetimibe and SimvastatinREMEDYREPACK INC.ANDACurrent
70518-1955Ezetimibe and SimvastatinEzetimibe and SimvastatinREMEDYREPACK INC.ANDACurrent
70518-1955Ezetimibe and SimvastatinEzetimibe and SimvastatinREMEDYREPACK INC.ANDACurrent
70518-1955Ezetimibe and SimvastatinEzetimibe and SimvastatinREMEDYREPACK INC.ANDACurrent
70518-1955Ezetimibe and SimvastatinEzetimibe and SimvastatinREMEDYREPACK INC.ANDACurrent
70518-1955Ezetimibe and SimvastatinEzetimibe and SimvastatinREMEDYREPACK INC.ANDACurrent