FDA.reportPublic FDA data

Application 075755

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDETABLET;ORALEQ 10MG BASENoNo
002FLUOXETINE HYDROCHLORIDEFLUOXETINE HYDROCHLORIDETABLET;ORALEQ 20MG BASENoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-0734FluoxetinefluoxetineMylan Pharmaceuticals Inc.ANDACurrent
0378-0735FluoxetinefluoxetineMylan Pharmaceuticals Inc.ANDACurrent
0615-5501Fluoxetine HydrochlorideFluoxetineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-5502Fluoxetine HydrochlorideFluoxetineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
21695-320Fluoxetine Hydrochloridefluoxetine hydrochlorideRebel Distributors CorpANDACurrent
21695-321Fluoxetine Hydrochloridefluoxetine hydrochlorideRebel Distributors CorpANDACurrent
63629-6790FluoxetinefluoxetineBryant Ranch PrepackANDACurrent
63629-6790FluoxetinefluoxetineBryant Ranch PrepackANDACurrent
70518-0971FluoxetinefluoxetineREMEDYREPACK INC.ANDACurrent
70518-0971FluoxetinefluoxetineREMEDYREPACK INC.ANDACurrent
70518-1757FluoxetinefluoxetineREMEDYREPACK INC.ANDACurrent
70518-2162FluoxetinefluoxetineREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18424SUPPL2015-08-31
23773ORIG2005-08-01
18423ORIG2004-06-04
43023ORIG2003-08-04
31008ORIG2001-08-02