FDA.reportPublic FDA data

Application 211653

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDETABLET;ORALEQ 10MG BASENoNo
002FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDETABLET;ORALEQ 20MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55700-808Fluoxetine HydrochlorideFluoxetine HydrochlorideQuality Care Products, LLCANDACurrent
68180-998Fluoxetine HydrochlorideFluoxetine HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-998Fluoxetine HydrochlorideFluoxetine HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-998Fluoxetine HydrochlorideFluoxetine HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-999Fluoxetine HydrochlorideFluoxetine HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-999Fluoxetine HydrochlorideFluoxetine HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-999Fluoxetine HydrochlorideFluoxetine HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent