FDA.reportPublic FDA data

Application 206298

Type
ANDA
Sponsor
TARO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DICLOFENAC SODIUMDICLOFENAC SODIUMGEL;TOPICAL3%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45861-063Diclofenac sodiumdiclofenac sodiumPharmaceutica North America, IncANDACurrent
51672-1363Diclofenac sodiumdiclofenac sodiumTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-1363Diclofenac sodiumdiclofenac sodiumTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
55700-980Diclofenac sodiumdiclofenac sodiumQuality Care Products, LLCANDACurrent
68788-7546Diclofenac sodiumdiclofenac sodiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7546Diclofenac sodiumdiclofenac sodiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-8236Diclofenac sodiumdiclofenac sodiumPreferred Pharmaceuticals Inc.ANDACurrent
70518-3464Diclofenac sodiumdiclofenac sodiumREMEDYREPACK INC.ANDACurrent
71085-003Diclofenac sodiumdiclofenac sodiumIPG PHARMACEUTICALS, INC.ANDACurrent
71205-538Diclofenac sodiumdiclofenac sodiumProficient Rx LPANDACurrent
72189-040DICLOFENAC SODIUMDICLOFENAC SODIUMDirect_RxANDACurrent
76420-275Diclofenac sodiumdiclofenac sodiumAsclemed USA, Inc.ANDACurrent
80425-0235Diclofenac SodiumDiclofenac SodiumAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32792ORIG2016-05-04