FDA.reportPublic FDA data

Application 090273

Type
ANDA
Sponsor
GLENMARK PHARMS

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
68071-1608Ciclopirox OlamineCiclopirox OlamineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1608Ciclopirox OlamineCiclopirox OlamineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1608Ciclopirox OlamineCiclopirox OlamineNuCare Pharmaceuticals,Inc.ANDACurrent
68258-3996Ciclopirox OlamineCiclopirox OlamineDispensing Solutions, Inc.ANDACurrent
68462-297Ciclopirox OlamineCiclopirox OlamineGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-297Ciclopirox OlamineCiclopirox OlamineGlenmark Pharmaceuticals Inc., USAANDACurrent
80425-0225Ciclopirox OlamineCiclopirox OlamineAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent