FDA.reportPublic FDA data

Application 040215

Type
ANDA
Sponsor
AKORN

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
17478-221Sulfacetamide SodiumSulfacetamide SodiumAkornANDACurrent
17478-221Sulfacetamide SodiumSulfacetamide SodiumAkorn, Inc.ANDACurrent
17478-221Sulfacetamide SodiumSulfacetamide SodiumAkorn, Inc.ANDACurrent
17478-221Sulfacetamide SodiumSulfacetamide SodiumAkorn, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42596ORIG2002-09-24
7582ORIG1999-05-25