FDA.reportPublic FDA data

Application 079209

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

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
0904-7195FluoxetineFluoxetineMajor PharmaceuticalsANDACurrent
65862-306FluoxetineFluoxetineAurobindo Pharma LimitedANDACurrent
65862-306FluoxetineFluoxetineAurobindo Pharma LimitedANDACurrent
65862-306FluoxetineFluoxetineAurobindo Pharma LimitedANDACurrent
65862-306FluoxetineFluoxetineAurobindo Pharma LimitedANDACurrent
65862-306FluoxetineFluoxetineAurobindo Pharma LimitedANDACurrent
65862-306FluoxetineFluoxetineAurobindo Pharma LimitedANDACurrent