FDA.reportPublic FDA data

Application 204306

Type
ANDA
Sponsor
MYLAN

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
0378-8750Diclofenac SodiumdiclofenacMylan Pharmaceuticals Inc.ANDACurrent
0378-8750Diclofenac SodiumdiclofenacMylan Pharmaceuticals Inc.ANDACurrent
0378-8750Diclofenac SodiumdiclofenacMylan Pharmaceuticals Inc.ANDACurrent
46122-711Diclofenac SodiumDiclofenacAmerisource BergenANDACurrent
57896-142Diclofenac SodiumDiclofenacGERI-CARE PHARMACEUTICAL CORPANDACurrent
58602-601Diclofenac SodiumDiclofenacAurohealth LLCANDACurrent
58602-602Diclofenac SodiumDiclofenacAurohealth LLCANDACurrent
58602-603Diclofenac SodiumDiclofenacAurohealth LLCANDACurrent