FDA.reportPublic FDA data

Application 016851

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002FMLFLUOROMETHOLONESUSPENSION/DROPS;OPHTHALMIC0.1%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
11980-211FMLfluorometholoneAllergan, Inc.NDACurrent
11980-211FMLfluorometholoneAllergan, Inc.NDACurrent
11980-211FMLfluorometholoneAllergan, Inc.NDACurrent
60758-880FLUOROMETHOLONEfluorometholonePacific Pharma, Inc.NDA AUTHORIZED GENERICCurrent
60758-880FLUOROMETHOLONEfluorometholonePacific Pharma, Inc.NDA AUTHORIZED GENERICCurrent
60758-880FLUOROMETHOLONEfluorometholonePacific Pharma, Inc.NDA AUTHORIZED GENERICCurrent
60758-880FLUOROMETHOLONEfluorometholonePacific Pharma, Inc.NDA AUTHORIZED GENERICCurrent
70518-1929FLUOROMETHOLONEfluorometholoneREMEDYREPACK INC.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10928SUPPL2013-02-14
504SUPPL2013-02-13
10927SUPPL2003-06-16
13043SUPPL2001-06-28