FDA.reportPublic FDA data

Application 075910

Type
ANDA
Sponsor
ACTAVIS ELIZABETH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DICLOFENAC SODIUMDICLOFENAC SODIUMTABLET, EXTENDED RELEASE;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-040Diclofenac Sodium Extended-ReleaseDiclofenac SodiumRebel Distributors Corp.ANDACurrent
45865-364Diclofenac SodiumDiclofenac SodiumMedsource PharmaceuticalsANDACurrent
50436-6925Diclofenac SodiumDiclofenac SodiumUnit Dose ServicesANDACurrent
61919-838DICLOFENAC SODIUMDICLOFENAC SODIUMDIRECT RXANDACurrent
61919-838DICLOFENAC SODIUMDICLOFENAC SODIUMDIRECT RXANDACurrent