FDA.reportPublic FDA data

Application 077849

Type
ANDA
Sponsor
LANNETT CO INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDESOLUTION;ORALEQ 20MG BASE/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
54838-523FluoxetineFluoxetine HydrochlorideLannett Company, Inc.ANDACurrent
54838-523FluoxetineFluoxetine HydrochlorideLannett Company, Inc.ANDACurrent
54838-523FluoxetineFluoxetine HydrochlorideLannett Company, Inc.ANDACurrent
54838-523FluoxetineFluoxetine HydrochlorideLannett Company, Inc.ANDACurrent
60687-244FluoxetineFluoxetine HydrochlorideAmerican Health PackagingANDACurrent
60687-244FluoxetineFluoxetine HydrochlorideAmerican Health PackagingANDACurrent
60687-244FluoxetineFluoxetine HydrochlorideAmerican Health PackagingANDACurrent
60687-244FluoxetineFluoxetine HydrochlorideAmerican Health PackagingANDACurrent