FDA.reportPublic FDA data

Application 209484

Type
ANDA
Sponsor
HI TECH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DICLOFENAC SODIUMDICLOFENAC SODIUMGEL;TOPICAL1%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50383-272Diclofenac SodiumDiclofenac SodiumHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-272Diclofenac SodiumDiclofenac SodiumHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-272Diclofenac SodiumDiclofenac SodiumHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-528Diclofenac SodiumDiclofenac SodiumAkornANDACurrent
70518-2673Diclofenac SodiumDiclofenac SodiumREMEDYREPACK INC.ANDACurrent
70518-2673Diclofenac SodiumDiclofenac SodiumREMEDYREPACK INC.ANDACurrent
70518-2673Diclofenac SodiumDiclofenac SodiumREMEDYREPACK INC.ANDACurrent