FDA.reportPublic FDA data

Application 204132

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45865-878Diclofenac SodiumDiclofenac Sodiummedsource pharmaceuticalsANDACurrent
50090-4019Diclofenac SodiumDiclofenac SodiumA-S Medication SolutionsANDACurrent
50436-3338Diclofenac Sodium 1.5%Diclofenac Sodium TopicalUnit Dose ServicesANDACurrent
51021-250Diclofenac SodiumDiclofenac SodiumSircle Laboratories, LLCANDACurrent
51021-372Diclofex DCDiclofenac Sodium and CapsaicinSircle Laboratories, LLCANDACurrent
51021-379Diclofex DCDiclofenac Sodium and Capsaicin OleoresinSircle Laboratories, LLCANDACurrent
51021-379Diclofex DCDiclofenac Sodium and Capsaicin OleoresinSircle Laboratories, LLCANDACurrent
51021-582Dynabac 5.0Diclofenac Sodium and CANNABIDIOLSircle Laboratories, LLCANDACurrent
51021-582Dynabac 5.0Diclofenac Sodium and CANNABIDIOLSircle Laboratories, LLCANDACurrent
55700-931Diclofenac Sodium 1.5%Diclofenac Sodium TopicalQuality Care Products, LLCANDACurrent
55700-931Diclofenac Sodium 1.5%Diclofenac Sodium TopicalQuality Care Products, LLCANDACurrent
61919-874DICLOFENAC SODIUMDICLOFENAC SODIUMDIRECT RXANDACurrent
61919-874DICLOFENAC SODIUMDICLOFENAC SODIUMDIRECT RXANDACurrent
63187-791Diclofenac SodiumDiclofenac SodiumProficient Rx LPANDACurrent
63187-791Diclofenac SodiumDiclofenac SodiumProficient Rx LPANDACurrent
63187-791Diclofenac SodiumDiclofenac SodiumProficient Rx LPANDACurrent
68180-538Diclofenac SodiumDiclofenac SodiumLupin Pharmaceuticals, Inc.ANDACurrent
68180-538Diclofenac SodiumDiclofenac SodiumLupin Pharmaceuticals, Inc.ANDACurrent
68180-538Diclofenac SodiumDiclofenac SodiumLupin Pharmaceuticals, Inc.ANDACurrent
68788-8084Diclofenac Sodium 1.5%Diclofenac Sodium TopicalPreferred Pharmaceuticals Inc.ANDACurrent
68788-8084Diclofenac Sodium 1.5%Diclofenac Sodium TopicalPreferred Pharmaceuticals Inc.ANDACurrent
69336-203Diclopakdiclofenac sodium, capsaicinSterling-Knight Pharmaceuticals, LLCANDACurrent
70512-038Diclofenac Sodium 1.5%Diclofenac Sodium TopicalSOLA PharmaceuticalsANDACurrent
70512-038Diclofenac Sodium 1.5%Diclofenac Sodium TopicalSOLA PharmaceuticalsANDACurrent
70512-038Diclofenac Sodium 1.5%Diclofenac Sodium TopicalSOLA PharmaceuticalsANDACurrent
70981-601Kapzin DCDiclofenac Sodium and CapsaicinChadwick Pharmaceuticals, IncANDACurrent
70981-701DiclosiacinDiclofenac Sodium and CapsaicinChadwick Pharmaceuticals, LLCANDACurrent
70981-701DiclosiacinDiclofenac Sodium and CapsaicinChadwick Pharmaceuticals, LLCANDACurrent
70981-701DiclosiacinDiclofenac Sodium and CapsaicinChadwick Pharmaceuticals, LLCANDACurrent
70981-702DiclosaicinDiclofenac Sodium and CapsaicinChadwick Pharmaceuticals, IncANDACurrent
70981-750Iclofenac CPDiclofenac Sodium and CapsaicinChadwick Pharmaceuticals, IncANDACurrent
71205-640Diclofenac Sodium 1.5%Diclofenac Sodium TopicalProficient Rx LPANDACurrent
72189-273DICLOFENAC SODIUMDICLOFENAC SODIUMDIRECT RXANDACurrent
73247-201CapsinacDiclofenac Sodium and CapsaicinBodysphere, LLCANDACurrent
73247-201CapsinacDiclofenac Sodium and CapsaicinBodysphere, LLCANDACurrent
73516-450ProfinacDiclofenac SodiumAshoka HealthANDACurrent
73516-605Biifenac 500Diclofenac Sodium and MENTHOL, UNSPECIFIED FORMAshoka HealthANDACurrent
73516-605Biifenac 500Diclofenac Sodium and MENTHOL, UNSPECIFIED FORMAshoka HealthANDACurrent
73516-605Biifenac 500Diclofenac Sodium and MENTHOL, UNSPECIFIED FORMAshoka HealthANDACurrent
73516-610Biifenac 1000Diclofenac Sodium and MENTHOL, UNSPECIFIED FORMAshoka HealthANDACurrent
73516-610Biifenac 1000Diclofenac Sodium and MENTHOL, UNSPECIFIED FORMAshoka HealthANDACurrent
73516-801ZicloproDiclofenac Sodium and CapsaicinAshoka HealthANDACurrent
76420-134Diclofenac SodiumDiclofenac SodiumAsclemed USA, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32514ORIG2015-08-25