FDA.reportPublic FDA data

Application 206993

Type
ANDA
Sponsor
CADILA PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDECAPSULE;ORALEQ 10MG BASENoNo
002FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDECAPSULE;ORALEQ 20MG BASENoNo
003FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDECAPSULE;ORALEQ 40MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
71209-040FluoxetineFluoxetineCadila Pharmaceuticals LimitedANDACurrent
71209-040FluoxetineFluoxetineCadila Pharmaceuticals LimitedANDACurrent
71209-040FluoxetineFluoxetineCadila Pharmaceuticals LimitedANDACurrent
71209-040FluoxetineFluoxetineCadila Pharmaceuticals LimitedANDACurrent
71209-040FluoxetineFluoxetineCadila Pharmaceuticals LimitedANDACurrent
71209-041FluoxetineFluoxetineCadila Pharmaceuticals LimitedANDACurrent
71209-041FluoxetineFluoxetineCadila Pharmaceuticals LimitedANDACurrent
71209-041FluoxetineFluoxetineCadila Pharmaceuticals LimitedANDACurrent
71209-041FluoxetineFluoxetineCadila Pharmaceuticals LimitedANDACurrent
71209-041FluoxetineFluoxetineCadila Pharmaceuticals LimitedANDACurrent
71209-042FluoxetineFluoxetineCadila Pharmaceuticals LimitedANDACurrent
71209-042FluoxetineFluoxetineCadila Pharmaceuticals LimitedANDACurrent
71209-042FluoxetineFluoxetineCadila Pharmaceuticals LimitedANDACurrent
71209-042FluoxetineFluoxetineCadila Pharmaceuticals LimitedANDACurrent
71209-042FluoxetineFluoxetineCadila Pharmaceuticals LimitedANDACurrent
72241-007FluoxetineFluoxetineModavar Pharmaceuticals LLCANDACurrent
72241-008FluoxetineFluoxetineModavar Pharmaceuticals LLCANDACurrent
72241-009FluoxetineFluoxetineModavar Pharmaceuticals LLCANDACurrent