FDA.reportPublic FDA data

Application 065175

Type
ANDA
Sponsor
XGEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NYSTATINNYSTATINPOWDER;TOPICAL100,000 UNITS/GMNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
39822-3015NystatinNystatinX-GEN Pharmaceuticals, Inc.ANDACurrent
39822-3015NystatinNystatinX-GEN Pharmaceuticals, Inc.ANDACurrent
39822-3015NystatinNystatinXGen Pharmaceuticals DJB, Inc.ANDACurrent
42543-052NystatinNystatinVensun Pharmaceuticals, Inc.ANDACurrent
42543-352NystatinNystatinVensun Pharmaceuticals, Inc.ANDACurrent
42543-352NystatinNystatinVensun Pharmaceuticals, Inc.ANDACurrent
42543-352NystatinNystatinVensun Pharmaceuticals, Inc.ANDACurrent
71205-106NystatinNystatinProficient Rx LPANDACurrent
71205-106NystatinNystatinProficient Rx LPANDACurrent