FDA.reportPublic FDA data

Application 211721

Type
ANDA
Sponsor
DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDETABLET;ORALEQ 60MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-114Fluoxetine hydrochlorideFluoxetine hydrochlorideNorthStar Rx LLCANDACurrent
16714-114Fluoxetine hydrochlorideFluoxetine hydrochlorideNorthStar Rx LLCANDACurrent
43598-632Fluoxetine hydrochlorideFluoxetine hydrochlorideDr. Reddy's Laboratories Inc.ANDACurrent
43598-632Fluoxetine hydrochlorideFluoxetine hydrochlorideDr. Reddy's Laboratories Inc.ANDACurrent