FDA.report

Application 206116

Type
ANDA
Sponsor
AMNEAL PHARMS

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001DICLOFENAC SODIUMDICLOFENAC SODIUMSOLUTION;TOPICAL1.5%NoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
45865-986Diclofenac SodiumDiclofenacmedsource pharmaceuticalsANDACurrent
50090-3316Diclofenac SodiumDiclofenacA-S Medication SolutionsANDACurrent
50090-3316Diclofenac SodiumDiclofenacA-S Medication SolutionsANDACurrent
50090-3316Diclofenac SodiumDiclofenacA-S Medication SolutionsANDACurrent
50090-3316Diclofenac SodiumDiclofenacA-S Medication SolutionsANDACurrent
53149-4902Diclofenac SodiumDiclofenacAll Pharma, LLCANDACurrent
53149-4902Diclofenac SodiumDiclofenacAll Pharma, LLCANDACurrent
55700-735Diclofenac SodiumDiclofenacQuality Care Products, LLCANDACurrent
55700-735Diclofenac SodiumDiclofenacQuality Care Products, LLCANDACurrent
65162-911Diclofenac SodiumDiclofenacAmneal Pharmaceuticals LLCANDACurrent
65162-911Diclofenac SodiumDiclofenacAmneal Pharmaceuticals LLCANDACurrent
65162-911Diclofenac SodiumDiclofenacAmneal Pharmaceuticals LLCANDACurrent
65162-911Diclofenac SodiumDiclofenacAmneal Pharmaceuticals LLCANDACurrent
65162-911Diclofenac SodiumDiclofenacAmneal Pharmaceuticals LLCANDACurrent
65162-911Diclofenac SodiumDiclofenacAmneal Pharmaceuticals LLCANDACurrent
65162-911Diclofenac SodiumDiclofenacAmneal Pharmaceuticals LLCANDACurrent
68788-7270Diclofenac SodiumDiclofenacPreferred Pharmaceuticals Inc.ANDACurrent
68788-7270Diclofenac SodiumDiclofenacPreferred Pharmaceuticals Inc.ANDACurrent
68788-7270Diclofenac SodiumDiclofenacPreferred Pharmaceuticals Inc.ANDACurrent
68788-7270Diclofenac SodiumDiclofenacPreferred Pharmaceuticals Inc.ANDACurrent
68788-7270Diclofenac SodiumDiclofenacPreferred Pharmaceuticals Inc.ANDACurrent
68788-7270Diclofenac SodiumDiclofenacPreferred Pharmaceuticals Inc.ANDACurrent
70518-0871Diclofenac SodiumDiclofenacREMEDYREPACK INC.ANDACurrent
70518-0871Diclofenac SodiumDiclofenacREMEDYREPACK INC.ANDACurrent
70518-0871Diclofenac SodiumDiclofenacREMEDYREPACK INC.ANDACurrent
70518-0871Diclofenac SodiumDiclofenacREMEDYREPACK INC.ANDACurrent
70518-0871Diclofenac SodiumDiclofenacREMEDYREPACK INC.ANDACurrent
72189-075DICLOFENAC SODIUMDICLOFENAC SODIUMDIRECT RXANDACurrent
72189-075DICLOFENAC SODIUMDICLOFENAC SODIUMDIRECT RXANDACurrent
76420-012Diclofenac SodiumDiclofenacAsclemed USA, Inc.ANDACurrent
76420-012Diclofenac SodiumDiclofenacAsclemed USA, Inc.ANDACurrent