FDA.reportPublic FDA data

Application 040091

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SULFADIAZINESULFADIAZINETABLET;ORAL500MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0185-0757SulfadiazineSulfadiazineEon Labs, Inc.ANDACurrent
0185-0757SulfadiazineSulfadiazineEon Labs, Inc.ANDACurrent
0185-0757SulfadiazineSulfadiazineEon Labs, Inc.ANDACurrent
42806-757SULFADIAZINEsulfadiazineEPIC PHARMA, LLCANDACurrent