FDA.reportPublic FDA data

Application 090745

Type
ANDA
Sponsor
SUN PHARM

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
47335-381DuloxetineDuloxetineSun Pharmaceutical Industries, Inc.ANDACurrent
47335-381DuloxetineDuloxetineSun Pharmaceutical Industries, Inc.ANDACurrent
47335-381DuloxetineDuloxetineSun Pharmaceutical Industries, Inc.ANDACurrent
47335-381DuloxetineDuloxetineSun Pharmaceutical Industries, Inc.ANDACurrent
47335-382DuloxetineDuloxetineSun Pharmaceutical Industries, Inc.ANDACurrent
47335-382DuloxetineDuloxetineSun Pharmaceutical Industries, Inc.ANDACurrent
47335-382DuloxetineDuloxetineSun Pharmaceutical Industries, Inc.ANDACurrent
47335-382DuloxetineDuloxetineSun Pharmaceutical Industries, Inc.ANDACurrent
47335-383DuloxetineDuloxetineSun Pharmaceutical Industries, Inc.ANDACurrent
47335-383DuloxetineDuloxetineSun Pharmaceutical Industries, Inc.ANDACurrent
47335-383DuloxetineDuloxetineSun Pharmaceutical Industries, Inc.ANDACurrent
47335-383DuloxetineDuloxetineSun Pharmaceutical Industries, Inc.ANDACurrent
50090-2212DuloxetineDuloxetineA-S Medication SolutionsANDACurrent
61919-483DULOXETINEDULOXETINEDIRECT RXANDACurrent
61919-483DULOXETINEDULOXETINEDIRECT RXANDACurrent
61919-483DULOXETINEDULOXETINEDIRECT RXANDACurrent
61919-636DULOXETINEDULOXETINEDIRECT RXANDACurrent
63629-5174DuloxetineDuloxetineBryant Ranch PrepackANDACurrent
63629-5174DuloxetineDuloxetineBryant Ranch PrepackANDACurrent
63629-5202DuloxetineDuloxetineBryant Ranch PrepackANDACurrent
63629-5202DuloxetineDuloxetineBryant Ranch PrepackANDACurrent
70518-0491DuloxetineDuloxetineREMEDYREPACK INC.ANDACurrent
70518-0491DuloxetineDuloxetineREMEDYREPACK INC.ANDACurrent
70518-1137DuloxetineDuloxetineREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9290ORIG2013-12-13