FDA.reportPublic FDA data

Application 203818

Type
ANDA
Sponsor
TARO

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
45865-118Diclofenac SodiumDiclofenac SodiumMedsource PharmaceuticalsANDACurrent
50436-0002Diclofenac sodiumdiclofenac sodiumUnit Dose ServicesANDACurrent
51672-1358Diclofenac SodiumDiclofenac SodiumTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-1358Diclofenac SodiumDiclofenac SodiumTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-1358Diclofenac SodiumDiclofenac SodiumTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
55700-966Diclofenac SodiumDiclofenac SodiumQuality Care Products, LLCANDACurrent
55700-966Diclofenac SodiumDiclofenac SodiumQuality Care Products, LLCANDACurrent
60760-296Diclofenac SodiumDiclofenac SodiumSt. Mary's Medical Park PharmacyANDACurrent
60760-296Diclofenac SodiumDiclofenac SodiumSt. Mary's Medical Park PharmacyANDACurrent
61919-392DICLOFENAC SODIUMDICLOFENAC SODIUMDIRECT RXANDACurrent
61919-392DICLOFENAC SODIUMDICLOFENAC SODIUMDIRECT RXANDACurrent
63187-725Diclofenac SodiumDiclofenac SodiumProficient Rx LPANDACurrent
63187-725Diclofenac SodiumDiclofenac SodiumProficient Rx LPANDACurrent
68788-7225Diclofenac sodiumdiclofenac sodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7225Diclofenac sodiumdiclofenac sodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7225Diclofenac sodiumdiclofenac sodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7225Diclofenac sodiumdiclofenac sodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7715Diclofenac SodiumDiclofenac SodiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7715Diclofenac SodiumDiclofenac SodiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7715Diclofenac SodiumDiclofenac SodiumPreferred Pharmaceuticals, Inc.ANDACurrent
70518-2811Diclofenac SodiumDiclofenac SodiumREMEDYREPACK INC.ANDACurrent
70518-2811Diclofenac SodiumDiclofenac SodiumREMEDYREPACK INC.ANDACurrent
70518-2811Diclofenac SodiumDiclofenac SodiumREMEDYREPACK INC.ANDACurrent
70518-2811Diclofenac SodiumDiclofenac SodiumREMEDYREPACK INC.ANDACurrent
71085-002Diclofenac sodiumdiclofenac sodiumIPG PHARMACEUTICALS, INC.ANDACurrent
71085-002Diclofenac sodiumdiclofenac sodiumIPG PHARMACEUTICALS, INC.ANDACurrent
71205-062Diclofenac sodiumdiclofenac sodiumProficient Rx LPANDACurrent
71205-062Diclofenac sodiumdiclofenac sodiumProficient Rx LPANDACurrent
71205-062Diclofenac sodiumdiclofenac sodiumProficient Rx LPANDACurrent
71205-579Diclofenac SodiumDiclofenac SodiumProficient Rx LPANDACurrent
71205-579Diclofenac SodiumDiclofenac SodiumProficient Rx LPANDACurrent
71248-003DiTholdiclofenac sodium/mentholFortus Pharma, LLCANDACurrent
71905-300DiMenthoDiclofenac Sodium 1.5% Solution, Menthol 10% Topical Liquid, and Kinesiology TapeLevins Pharmaceuticals, LLCANDACurrent
72189-319DICLOFENAC SODIUMDICLOFENAC SODIUMDirectRxANDACurrent
73272-301DiclostreamDiclofenac Sodium 1.5% Solution and Menthol 10% Topical LiquidUpstream Pharma, LLCANDACurrent
80175-1358Diclofenac SodiumDiclofenac SodiumCentral PackagingANDACurrent
80175-1358Diclofenac SodiumDiclofenac SodiumCentral PackagingANDACurrent
80175-1358Diclofenac SodiumDiclofenac SodiumCentral PackagingANDACurrent