Application 062124

Type
ANDA
Sponsor
FOUGERA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002NYSTATINNYSTATINOINTMENT;TOPICAL100,000 UNITS/GMNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0168-0007NystatinnystatinE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
42254-284NystatinnystatinRebel Distributors CorpANDACurrent
50436-1425NystatinnystatinUnit Dose ServicesANDACurrent