FDA.reportPublic FDA data

Application 202133

Type
NDA
Sponsor
ALVOGEN

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47781-600Fluoxetine HydrochlorideFluoxetine HydrochlorideAlvogen Inc.NDACurrent
47781-600Fluoxetine HydrochlorideFluoxetine HydrochlorideAlvogen Inc.NDACurrent
47781-600Fluoxetine HydrochlorideFluoxetine HydrochlorideAlvogen Inc.NDACurrent
47781-600Fluoxetine HydrochlorideFluoxetine HydrochlorideAlvogen Inc.NDACurrent
47781-600Fluoxetine HydrochlorideFluoxetine HydrochlorideAlvogen Inc.NDACurrent
49909-005Fluoxetine HClFluoxetine HClEdgemont Pharmaceuticals, LLCNDACurrent
52427-576Fluoxetine HClFluoxetine HClAlmatica Pharma Inc.NDACurrent
52427-576Fluoxetine HClFluoxetine HClAlmatica Pharma Inc.NDACurrent
52427-576Fluoxetine HClFluoxetine HClAlmatica Pharma Inc.NDACurrent
52427-576Fluoxetine HClFluoxetine HClAlmatica Pharma Inc.NDACurrent
52427-576Fluoxetine HClFluoxetine HClAlmatica Pharma Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75245SUPPL 2023-08-22
75244SUPPL 2023-08-22
75181SUPPL 2023-08-21
75180SUPPL 2023-08-21
75179SUPPL 2023-08-21
68783SUPPL2021-09-24
68782SUPPL2021-09-24
68734SUPPL2021-09-23
46746SUPPL2017-01-10
46745SUPPL2017-01-10
46744SUPPL2017-01-10
46692SUPPL2017-01-06
46691SUPPL2017-01-06
40130SUPPL2014-07-30
32191SUPPL2014-07-23
24408ORIG2012-04-24
22873ORIG2012-04-24
40129ORIG2011-10-12
32190ORIG2011-10-12