FDA.reportPublic FDA data

Application 080029

Type
ANDA
Sponsor
PERRIGO CO TENNESSEE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SULFACETAMIDE SODIUMSULFACETAMIDE SODIUMOINTMENT;OPHTHALMIC10%NoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0574-4190Sulfacetamide SodiumSulfacetamide SodiumPadagis US LLCANDACurrent
0574-4190Sulfacetamide SodiumSulfacetamide SodiumPaddock Laboratories, LLCANDACurrent