FDA.reportPublic FDA data

Application 209082

Type
ANDA
Sponsor
LYNE

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0374-5160NystatinNystatin OintmentLyne Laboratories, Inc.ANDACurrent
69315-307NYSTATINNYSTATINLeading Pharma, LLCANDACurrent
69315-307NYSTATINNYSTATINLeading Pharma, LLCANDACurrent