FDA.reportPublic FDA data

Application 204623

Type
NDA
Sponsor
HORIZON

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PENNSAIDDICLOFENAC SODIUMSOLUTION;TOPICAL2%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0574-0167DICLOFENAC SODIUMdiclofenac sodiumPadagis US LLCNDA AUTHORIZED GENERICCurrent
63629-9603DICLOFENAC SODIUMdiclofenac sodiumBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
70518-2492Pennsaiddiclofenac sodiumREMEDYREPACK INC.NDACurrent
70518-2492Pennsaiddiclofenac sodiumREMEDYREPACK INC.NDACurrent
70518-2492Pennsaiddiclofenac sodiumREMEDYREPACK INC.NDACurrent
70518-2492Pennsaiddiclofenac sodiumREMEDYREPACK INC.NDACurrent
70518-2492Pennsaiddiclofenac sodiumREMEDYREPACK INC.NDACurrent
70748-335Diclofenac SodiumDiclofenac SodiumLupin Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
75987-040Pennsaiddiclofenac sodiumHorizon Therapeutics USA, Inc.NDACurrent
75987-040Pennsaiddiclofenac sodiumHorizon Therapeutics USA, Inc.NDACurrent
75987-040Pennsaiddiclofenac sodiumHorizon Therapeutics USA, Inc.NDACurrent
75987-040Pennsaiddiclofenac sodiumHorizon Therapeutics USA, Inc.NDACurrent
75987-040Pennsaiddiclofenac sodiumHorizon Therapeutics USA, Inc.NDACurrent
75987-040Pennsaiddiclofenac sodiumHorizon Therapeutics USA, Inc.NDACurrent
75987-040Pennsaiddiclofenac sodiumHorizon Pharma Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80396SUPPL 2024-11-25
80395SUPPL 2024-11-25
80314SUPPL 2024-11-22
70017SUPPL2022-01-31
70004SUPPL2022-01-31
67745SUPPL2021-06-08
67744SUPPL2021-06-08
67734SUPPL2021-06-08
67362SUPPL2021-05-03
67361SUPPL2021-05-03
67287SUPPL2021-04-30
63564SUPPL2020-06-15
63486SUPPL2020-06-11
40400SUPPL2016-05-11
10366SUPPL2016-05-10
40399SUPPL2014-11-07
10365SUPPL2014-11-07
43469ORIG2014-10-07
24473ORIG2014-10-07
19576SUPPL2014-07-11
40398ORIG2014-01-17
10364ORIG2014-01-17