Application 206493

Type
ANDA
Sponsor
ACTAVIS MID ATLANTIC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DICLOFENAC SODIUMDICLOFENAC SODIUMGEL;TOPICAL3%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0472-1783Diclofenac SodiumDiclofenac SodiumActavis Pharma, Inc.ANDACurrent
0472-1783Diclofenac SodiumDiclofenac SodiumActavis Pharma, Inc.ANDACurrent
0472-1783Diclofenac SodiumDiclofenac SodiumActavis Pharma, Inc.ANDACurrent
68788-7518Diclofenac SodiumDiclofenac SodiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7518Diclofenac SodiumDiclofenac SodiumPreferred Pharmaceuticals, Inc.ANDACurrent
76420-261Diclofenac SodiumDiclofenac SodiumAsclemed USA, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10574ORIG2015-12-07