FDA.reportPublic FDA data

Application 089560

Type
ANDA
Sponsor
SANDOZ INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SULFACETAMIDE SODIUMSULFACETAMIDE SODIUMSOLUTION/DROPS;OPHTHALMIC10%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-525Sulfacetamide SodiumSulfacetamide SodiumRebel Distributors CorpANDACurrent
52959-117Sulfacetamide SodiumSulfacetamide SodiumH.J. Harkins Company, Inc.ANDACurrent
61314-701Sulfacetamide SodiumSulfacetamide SodiumSandoz Inc.ANDACurrent
61314-701Sulfacetamide SodiumSulfacetamide SodiumSandoz Inc.ANDACurrent
61314-701Sulfacetamide SodiumSulfacetamide SodiumSandoz Inc.ANDACurrent
61314-701Sulfacetamide SodiumSulfacetamide SodiumSandoz Inc.ANDACurrent
66267-941Sulfacetamide SodiumSulfacetamide SodiumNuCare Pharmaceuticals,Inc.ANDACurrent
66267-941Sulfacetamide SodiumSulfacetamide SodiumNuCare Pharmaceuticals,Inc.ANDACurrent
68387-491SULFACETAMIDE SODIUMSULFACETAMIDE SODIUMKeltman Pharmaceuticals Inc.ANDACurrent
68788-7015Sulfacetamide SodiumSulfacetamide SodiumPreferred PharmaceuticalsANDACurrent
76420-076Sulfacetamide SodiumSulfacetamide SodiumAsclemed USA, Inc.ANDACurrent
76420-076Sulfacetamide SodiumSulfacetamide SodiumAsclemed USA, Inc.ANDACurrent