FDA.reportPublic FDA data

Application 203167

Type
ANDA
Sponsor
XGEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDEINJECTABLE;INJECTION1MG/10ML (0.1MG/ML)NoNo
002CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDEINJECTABLE;INJECTION5MG/10ML (0.5MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
39822-2000ClonidineClonidineX-GEN Pharmaceuticals, Inc.ANDACurrent
39822-2000ClonidineClonidineXGen Pharmaceuticals DJB, Inc.ANDACurrent
39822-2000ClonidineClonidineX-GEN Pharmaceuticals, Inc.ANDACurrent
39822-2000ClonidineClonidineXGen Pharmaceuticals DJB, Inc.ANDACurrent
39822-2000ClonidineClonidineXGen Pharmaceuticals DJB, Inc.ANDACurrent
39822-2010ClonidineClonidineX-GEN Pharmaceuticals, Inc.ANDACurrent
39822-2010ClonidineClonidineXGen Pharmaceuticals DJB, Inc.ANDACurrent
39822-2010ClonidineClonidineX-GEN Pharmaceuticals, Inc.ANDACurrent
39822-2010ClonidineClonidineXGen Pharmaceuticals DJB, Inc.ANDACurrent
39822-2010ClonidineClonidineXGen Pharmaceuticals DJB, Inc.ANDACurrent