FDA.reportPublic FDA data

Application 078031

Type
ANDA
Sponsor
SANDOZ INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DICLOFENAC SODIUMDICLOFENAC SODIUMSOLUTION/DROPS;OPHTHALMIC0.1%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
53217-099Diclofenac SodiumDiclofenac SodiumAidarex Pharmaceuticals LLCANDACurrent
61314-014Diclofenac SodiumDiclofenac SodiumSandoz IncANDACurrent
61314-014Diclofenac SodiumDiclofenac SodiumSandoz IncANDACurrent
61314-014Diclofenac SodiumDiclofenac SodiumSandoz IncANDACurrent
68071-1653Diclofenac SodiumDiclofenac SodiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1653Diclofenac SodiumDiclofenac SodiumNuCare Pharmaceuticals,Inc.ANDACurrent