FDA.report

Application 090776

Type
ANDA
Sponsor
ACTAVIS ELIZABETH

Related Records

Application Products

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

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0228-2890DuloxetineDuloxetineActavis Pharma, Inc.ANDACurrent
0228-2890DuloxetineDuloxetineActavis Pharma, Inc.ANDACurrent
0228-2890DuloxetineDuloxetineActavis Pharma, Inc.ANDACurrent
0228-2890DuloxetineDuloxetineActavis Pharma, Inc.ANDACurrent
0228-2890DuloxetineDuloxetineActavis Pharma, Inc.ANDACurrent
0228-2890DuloxetineDuloxetineActavis Pharma, Inc.ANDACurrent
0228-2891DuloxetineDuloxetineActavis Pharma, Inc.ANDACurrent
0228-2891DuloxetineDuloxetineActavis Pharma, Inc.ANDACurrent
0228-2891DuloxetineDuloxetineActavis Pharma, Inc.ANDACurrent
0228-2891DuloxetineDuloxetineActavis Pharma, Inc.ANDACurrent
0228-2891DuloxetineDuloxetineActavis Pharma, Inc.ANDACurrent
0228-2891DuloxetineDuloxetineActavis Pharma, Inc.ANDACurrent
0228-2892DuloxetineDuloxetineActavis Pharma, Inc.ANDACurrent
0228-2892DuloxetineDuloxetineActavis Pharma, Inc.ANDACurrent
0228-2892DuloxetineDuloxetineActavis Pharma, Inc.ANDACurrent
0228-2892DuloxetineDuloxetineActavis Pharma, Inc.ANDACurrent
0228-2892DuloxetineDuloxetineActavis Pharma, Inc.ANDACurrent
0228-2892DuloxetineDuloxetineActavis Pharma, Inc.ANDACurrent
50090-2517DuloxetineDuloxetineA-S Medication SolutionsANDACurrent
50436-2892DuloxetineDuloxetineUnit Dose ServicesANDACurrent
63629-8748DuloxetineDuloxetineBryant Ranch PrepackANDACurrent
63629-8748DuloxetineDuloxetineBryant Ranch PrepackANDACurrent
63629-8748DuloxetineDuloxetineBryant Ranch PrepackANDACurrent
70518-1891DuloxetineDuloxetineREMEDYREPACK INC.ANDACurrent
71205-525DuloxetineDuloxetineProficient Rx LPANDACurrent
71205-525DuloxetineDuloxetineProficient Rx LPANDACurrent
76420-236DuloxetineDuloxetineAsclemed USA, Inc.ANDACurrent
80425-0086CymbaltaDuloxetine HClAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0086Duloxetine HCLDuloxetine HCLAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0086Duloxetine HCLDuloxetine HCLAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0086Duloxetine HCLDuloxetine HCLAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0086Duloxetine HCLDuloxetine HCLAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent

Documents

DocumentSubmission typeDate
31493ORIG2013-12-20