Application 091104

Type
ANDA
Sponsor
AM REGENT

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
40042-052Clonidine HydrochlorideClonidine HydrochloridePharmaForce, Inc.ANDACurrent
40042-053Clonidine HydrochlorideClonidine HydrochloridePharmaForce, Inc.ANDACurrent