FDA.reportPublic FDA data

Application 090739

Type
ANDA
Sponsor
ZYDUS HLTHCARE

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
004DULOXETINE HYDROCHLORIDEDULOXETINE HYDROCHLORIDECAPSULE, DELAYED REL PELLETS;ORALEQ 40MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-4011DuloxetineDuloxetineA-S Medication SolutionsANDACurrent
50090-4403DuloxetineDuloxetineA-S Medication SolutionsANDACurrent
50436-0387DuloxetineDuloxetineUnit Dose ServicesANDACurrent
65841-799DuloxetineDuloxetineZydus Lifesciences LimitedANDACurrent
65841-799DuloxetineDuloxetineCadila Healthcare LimitedANDACurrent
65841-799DuloxetineDuloxetineCadila Healthcare LimitedANDACurrent
65841-799DuloxetineDuloxetineCadila Healthcare LimitedANDACurrent
65841-800DuloxetineDuloxetineZydus Lifesciences LimitedANDACurrent
65841-800DuloxetineDuloxetineCadila Healthcare LimitedANDACurrent
65841-800DuloxetineDuloxetineCadila Healthcare LimitedANDACurrent
65841-800DuloxetineDuloxetineCadila Healthcare LimitedANDACurrent
65841-801DuloxetineDuloxetineZydus Lifesciences LimitedANDACurrent
65841-801DuloxetineDuloxetineCadila Healthcare LimitedANDACurrent
65841-801DuloxetineDuloxetineCadila Healthcare LimitedANDACurrent
65841-801DuloxetineDuloxetineCadila Healthcare LimitedANDACurrent
68001-255DuloxetineDuloxetineBluePoint LaboratoriesANDACurrent
68001-255DuloxetineDuloxetineBluePoint LaboratoriesANDACurrent
68001-256DuloxetineDuloxetineBluePoint LaboratoriesANDACurrent
68001-256DuloxetineDuloxetineBluePoint LaboratoriesANDACurrent
68001-257DuloxetineDuloxetineBluePoint LaboratoriesANDACurrent
68001-257DuloxetineDuloxetineBluePoint LaboratoriesANDACurrent
68382-385DuloxetineDuloxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-385DuloxetineDuloxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-385DuloxetineDuloxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-385DuloxetineDuloxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-386DuloxetineDuloxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-386DuloxetineDuloxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-386DuloxetineDuloxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-386DuloxetineDuloxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-387DuloxetineDuloxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-387DuloxetineDuloxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-387DuloxetineDuloxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-387DuloxetineDuloxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
70518-1066DuloxetineDuloxetineREMEDYREPACK INC.ANDACurrent
70518-1066DuloxetineDuloxetineREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9289ORIG2014-01-10