FDA.reportPublic FDA data

Application 090728

Type
ANDA
Sponsor
ZYDUS PHARMS

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
65841-774DuloxetineDuloxetineCadila Healthcare LimitedANDACurrent
65841-775DuloxetineDuloxetineCadila Healthcare LimitedANDACurrent
65841-776DuloxetineDuloxetineCadila Healthcare LimitedANDACurrent
70710-1537DuloxetineDuloxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1537DuloxetineDuloxetineZydus Pharmaceuticals USA Inc.ANDACurrent
70710-1537DuloxetineDuloxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1538DuloxetineDuloxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1538DuloxetineDuloxetineZydus Pharmaceuticals USA Inc.ANDACurrent
70710-1538DuloxetineDuloxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1539DuloxetineDuloxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1539DuloxetineDuloxetineZydus Pharmaceuticals USA Inc.ANDACurrent
70710-1539DuloxetineDuloxetineZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1344DuloxetineDuloxetineCadila Healthcare LimitedANDACurrent
70771-1344DuloxetineDuloxetineCadila Healthcare LimitedANDACurrent
70771-1344DuloxetineDuloxetineZydus Lifesciences LimitedANDACurrent
70771-1344DuloxetineDuloxetineCadila Healthcare LimitedANDACurrent
70771-1345DuloxetineDuloxetineCadila Healthcare LimitedANDACurrent
70771-1345DuloxetineDuloxetineCadila Healthcare LimitedANDACurrent
70771-1345DuloxetineDuloxetineZydus Lifesciences LimitedANDACurrent
70771-1345DuloxetineDuloxetineCadila Healthcare LimitedANDACurrent
70771-1346DuloxetineDuloxetineCadila Healthcare LimitedANDACurrent
70771-1346DuloxetineDuloxetineCadila Healthcare LimitedANDACurrent
70771-1346DuloxetineDuloxetineZydus Lifesciences LimitedANDACurrent
70771-1346DuloxetineDuloxetineCadila Healthcare LimitedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9288ORIG2014-01-10