FDA.reportPublic FDA data

Application 075465

Type
ANDA
Sponsor
MARKSANS PHARMA

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
25000-147FluoxetineFluoxetine HydrochlorideMARKSANS PHARMA LIMITEDANDACurrent
25000-147FluoxetineFluoxetine HydrochlorideMARKSANS PHARMA LIMITEDANDACurrent
25000-147FluoxetineFluoxetine HydrochlorideMARKSANS PHARMA LIMITEDANDACurrent
25000-148FluoxetineFluoxetine HydrochlorideMARKSANS PHARMA LIMITEDANDACurrent
25000-148FluoxetineFluoxetine HydrochlorideMARKSANS PHARMA LIMITEDANDACurrent
25000-148FluoxetineFluoxetine HydrochlorideMARKSANS PHARMA LIMITEDANDACurrent
25000-149FluoxetineFluoxetine HydrochlorideMARKSANS PHARMA LIMITEDANDACurrent
25000-149FluoxetineFluoxetine HydrochlorideMARKSANS PHARMA LIMITEDANDACurrent
25000-149FluoxetineFluoxetine HydrochlorideMARKSANS PHARMA LIMITEDANDACurrent
45865-451FluoxetineFluoxetineMedsource PharmaceuticalsANDACurrent
49483-701FluoxetineFluoxetine HydrochlorideTIME CAP LABORATORIES, INC.ANDACurrent
49483-701FluoxetineFluoxetine HydrochlorideTIME CAP LABORATORIES, INC.ANDACurrent
49483-702FluoxetineFluoxetine HydrochlorideTIME CAP LABORATORIES, INC.ANDACurrent
49483-702FluoxetineFluoxetine HydrochlorideTIME CAP LABORATORIES, INC.ANDACurrent
49483-703FluoxetineFluoxetine HydrochlorideTIME CAP LABORATORIES, INC.ANDACurrent
49483-703FluoxetineFluoxetine HydrochlorideTIME CAP LABORATORIES, INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44258ORIG2005-08-01
39486ORIG2004-06-04
30894ORIG2004-06-04
8679ORIG2004-06-04
42998ORIG2003-08-04