FDA.reportPublic FDA data

Application 075281

Type
ANDA
Sponsor
MYLAN PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002DICLOFENAC SODIUMDICLOFENAC SODIUMTABLET, DELAYED RELEASE;ORAL50MGNoNo
003DICLOFENAC SODIUMDICLOFENAC SODIUMTABLET, DELAYED RELEASE;ORAL75MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-6280Diclofenac Sodiumdiclofenac sodiumMylan Pharmaceuticals Inc.ANDACurrent
0378-6280Diclofenac Sodiumdiclofenac sodiumMylan Pharmaceuticals Inc.ANDACurrent
0378-6281Diclofenac Sodiumdiclofenac sodiumMylan Pharmaceuticals Inc.ANDACurrent
0378-6281Diclofenac Sodiumdiclofenac sodiumMylan Pharmaceuticals Inc.ANDACurrent
51079-224Diclofenac Sodiumdiclofenac sodiumMylan Institutional Inc.ANDACurrent
51079-224Diclofenac Sodiumdiclofenac sodiumMylan Institutional Inc.ANDACurrent
51079-466Diclofenac Sodiumdiclofenac sodiumMylan Institutional Inc.ANDACurrent
68788-9185Diclofenac Sodiumdiclofenac sodiumPreferred Pharmaceuticals, Inc.ANDACurrent