FDA.reportPublic FDA data

Application 078463

Type
ANDA
Sponsor
ACP NIMBLE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CICLOPIROXCICLOPIROXCREAM;TOPICAL0.77%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0713-0638Ciclopirox OlamineCiclopirox OlamineG&W Laboratories, Inc.ANDACurrent
0713-0638Ciclopirox OlamineCiclopirox OlamineCosette Pharmaceuticals, Inc.ANDACurrent
0713-0638Ciclopirox OlamineCiclopirox OlamineCosette Pharmaceuticals, Inc.ANDACurrent
0713-0638Ciclopirox OlamineCiclopirox OlamineCosette Pharmaceuticals, Inc.ANDACurrent