FDA.reportPublic FDA data

Application 202027

Type
ANDA
Sponsor
APOTEX INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DICLOFENAC SODIUMDICLOFENAC SODIUMSOLUTION;TOPICAL1.5%NoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-4016Diclofenac SodiumDiclofenac SodiumA-S Medication SolutionsANDACurrent
50436-3990Diclofenac SodiumDiclofenac SodiumUnit Dose ServicesANDACurrent
60505-0399Diclofenac SodiumDiclofenac SodiumApotex Corp.ANDACurrent
60505-0399Diclofenac SodiumDiclofenac SodiumApotex Corp.ANDACurrent
60505-0399Diclofenac SodiumDiclofenac SodiumApotex Corp.ANDACurrent
60505-0399Diclofenac SodiumDiclofenac SodiumApotex Corp.ANDACurrent
60505-0399Diclofenac SodiumDiclofenac SodiumApotex Corp.ANDACurrent
60505-0399Diclofenac SodiumDiclofenac SodiumApotex Corp.ANDACurrent
61919-343DICLOFENAC SODIUMDICLOFENAC SODIUMDIRECT RXANDACurrent
61919-343DICLOFENAC SODIUMDICLOFENAC SODIUMDIRECT RXANDACurrent
68788-7097Diclofenac SodiumDiclofenac SodiumPreferred Pharmaceuticals Inc.ANDACurrent
69329-510Diclotral Pakdiclofenac sodium, capsaicinPatchwerx Labs, Inc.ANDACurrent
69837-399DICLOFENAC SODIUMDICLOFENAC SODIUMInternational Brand Management, LLCANDACurrent
69837-500Sure Result DSS Premium PakDICLOFENAC SODIUM, CAPSAICINInternational Brand Management, LLCANDACurrent
70518-0572Diclofenac SodiumDiclofenac SodiumREMEDYREPACK INC.ANDACurrent
70518-0572Diclofenac SodiumDiclofenac SodiumREMEDYREPACK INC.ANDACurrent
70518-0572Diclofenac SodiumDiclofenac SodiumREMEDYREPACK INC.ANDACurrent
70518-0572Diclofenac SodiumDiclofenac SodiumREMEDYREPACK INC.ANDACurrent
72835-201VarophenDiclofenac Sodium and Menthol, Methyl salicylateV2 Pharma, LLCANDACurrent
72835-201VarophenDiclofenac Sodium and Menthol, Methyl salicylateV2 Pharma, LLCANDACurrent
72835-201VarophenDiclofenac Sodium and Menthol, Methyl salicylateV2 Pharma, LLCANDACurrent