FDA.reportPublic FDA data

Application 202336

Type
ANDA
Sponsor
INVENTIA

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
23155-654duloxetineduloxetineHeritage Pharmaceuticals Inc.ANDACurrent
23155-654duloxetineduloxetineHeritage Pharmaceuticals Inc.ANDACurrent
23155-655duloxetineduloxetineHeritage Pharmaceuticals Inc.ANDACurrent
23155-655duloxetineduloxetineHeritage Pharmaceuticals Inc.ANDACurrent
23155-656duloxetineduloxetineHeritage Pharmaceuticals Inc.ANDACurrent
23155-656duloxetineduloxetineHeritage Pharmaceuticals Inc.ANDACurrent
49252-007duloxetineduloxetineInventia Healthcare Private LimitedANDACurrent
49252-007duloxetineduloxetineInventia Healthcare Private LimitedANDACurrent
49252-007duloxetineduloxetineInventia Healthcare Private LimitedANDACurrent
49252-008duloxetineduloxetineInventia Healthcare Private LimitedANDACurrent
49252-008duloxetineduloxetineInventia Healthcare Private LimitedANDACurrent
49252-008duloxetineduloxetineInventia Healthcare Private LimitedANDACurrent
49252-009duloxetineduloxetineInventia Healthcare Private LimitedANDACurrent
49252-009duloxetineduloxetineInventia Healthcare Private LimitedANDACurrent
49252-009duloxetineduloxetineInventia Healthcare Private LimitedANDACurrent
68788-6427duloxetineduloxetinePreferred Pharmaceuticals Inc.ANDACurrent
68788-6427duloxetineduloxetinePreferred Pharmaceuticals Inc.ANDACurrent
69097-297duloxetineduloxetineCipla USA Inc.ANDACurrent
69097-298duloxetineduloxetineCipla USA Inc.ANDACurrent
69097-299duloxetineduloxetineCipla USA Inc.ANDACurrent