FDA.reportPublic FDA data

Application 078233

Type
ANDA
Sponsor
ACP NIMBLE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CICLOPIROXCICLOPIROXSOLUTION;TOPICAL8%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0713-0317CiclopiroxCICLOPIROXCosette Pharmaceuticals, Inc.ANDACurrent
0713-0317CiclopiroxCICLOPIROXCosette Pharmaceuticals, Inc.ANDACurrent
0713-0317CiclopiroxCICLOPIROXG&W Laboratories, Inc.ANDACurrent
0713-0317CiclopiroxCICLOPIROXCosette Pharmaceuticals, Inc.ANDACurrent
43538-500CiclodanciclopiroxMedimetriks Pharmaceuticals, Inc.ANDACurrent
43538-500CiclodanciclopiroxMedimetriks Pharmaceuticals, Inc.ANDACurrent
43538-500CiclodanciclopiroxMedimetriks Pharmaceuticals, Inc.ANDACurrent
43538-501CiclodanciclopiroxMedimetriks Pharmaceuticals, Inc.ANDACurrent
51672-5302CiclopiroxciclopiroxTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-5302CiclopiroxciclopiroxTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
68071-4977CiclopiroxciclopiroxNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4977CiclopiroxciclopiroxNuCare Pharmaceuticals,Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9134ORIG2007-09-25