FDA.reportPublic FDA data

Application 203197

Type
ANDA
Sponsor
ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDECAPSULE, DELAYED REL PELLETS;ORALEQ 20MG BASENoNo
002DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDECAPSULE, DELAYED REL PELLETS;ORALEQ 30MG BASENoNo
003DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDECAPSULE, DELAYED REL PELLETS;ORALEQ 60MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67877-263DuloxetineDuloxetineAscend Laboratories, LLCANDACurrent
67877-263DuloxetineDuloxetineAscend Laboratories, LLCANDACurrent
67877-263DuloxetineDuloxetineAscend Laboratories, LLCANDACurrent
67877-263DuloxetineDuloxetineAscend Laboratories, LLCANDACurrent
67877-264DuloxetineDuloxetineAscend Laboratories, LLCANDACurrent
67877-264DuloxetineDuloxetineAscend Laboratories, LLCANDACurrent
67877-264DuloxetineDuloxetineAscend Laboratories, LLCANDACurrent
67877-264DuloxetineDuloxetineAscend Laboratories, LLCANDACurrent
67877-265DuloxetineDuloxetineAscend Laboratories, LLCANDACurrent
67877-265DuloxetineDuloxetineAscend Laboratories, LLCANDACurrent
67877-265DuloxetineDuloxetineAscend Laboratories, LLCANDACurrent
67877-265DuloxetineDuloxetineAscend Laboratories, LLCANDACurrent
68788-7828DuloxetineDuloxetinePreferred Pharmaceuticals Inc.ANDACurrent
68788-7828DuloxetineDuloxetinePreferred Pharmaceuticals Inc.ANDACurrent
70518-2855DuloxetineDuloxetineREMEDYREPACK INC.ANDACurrent
70518-2855DuloxetineDuloxetineREMEDYREPACK INC.ANDACurrent
70518-2855DuloxetineDuloxetineREMEDYREPACK INC.ANDACurrent
71205-445DuloxetineDuloxetineProficient Rx LPANDACurrent
71335-1672DuloxetineDuloxetineBryant Ranch PrepackANDACurrent
71335-1672DuloxetineDuloxetineBryant Ranch PrepackANDACurrent
71335-1672DuloxetineDuloxetineBryant Ranch PrepackANDACurrent
80425-0012Duloxetine HCLDuloxetine HCLAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0012Duloxetine HCLDuloxetine HCLAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0012Duloxetine HCLDuloxetine HCLAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0012Duloxetine HCLDuloxetine HCLAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent