FDA.reportPublic FDA data

Application 209234

Type
ANDA
Sponsor
ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EZETIMIBEEZETIMIBETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-7103EzetimibeEzetimibeMajor PharmaceuticalsANDACurrent
0904-7103EzetimibeEzetimibeMajor PharmaceuticalsANDACurrent
50090-3657EzetimibeEzetimibeA-S Medication SolutionsANDACurrent
50090-3657EzetimibeEzetimibeA-S Medication SolutionsANDACurrent
60687-373EzetimibeEzetimibeAmerican Health PackagingANDACurrent
60687-373EzetimibeEzetimibeAmerican Health PackagingANDACurrent
60687-373EzetimibeEzetimibeAmerican Health PackagingANDACurrent
67877-490EzetimibeEzetimibeAscend Laboratories, LLCANDACurrent
67877-490EzetimibeEzetimibeAscend Laboratories, LLCANDACurrent
68788-8297EzetimibeEzetimibePreferred Pharmaceuticals Inc.ANDACurrent
70518-1783EzetimibeEzetimibeREMEDYREPACK INC.ANDACurrent
70518-1927EzetimibeEzetimibeREMEDYREPACK INC.ANDACurrent
70518-2262EzetimibeEzetimibeREMEDYREPACK INC.ANDACurrent
70518-2262EzetimibeEzetimibeREMEDYREPACK INC.ANDACurrent
70518-2262EzetimibeEzetimibeREMEDYREPACK INC.ANDACurrent
71205-277EzetimibeEzetimibeProficient Rx LPANDACurrent
71205-277EzetimibeEzetimibeProficient Rx LPANDACurrent
71205-277EzetimibeEzetimibeProficient Rx LPANDACurrent
71335-1127EzetimibeEzetimibeBryant Ranch PrepackANDACurrent
72189-118EZETIMIBEEZETIMIBEdirect rxANDACurrent
72189-118EZETIMIBEEZETIMIBEdirect rxANDACurrent