Application 080439

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDETABLET;ORAL10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo
002CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDETABLET;ORAL25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo
003CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDETABLET;ORAL50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo
004CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDETABLET;ORAL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo
005CHLORPROMAZINE HYDROCHLORIDECHLORPROMAZINE HYDROCHLORIDETABLET;ORAL200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-1546ChlorpromazineChlorpromazine HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-1547ChlorpromazineChlorpromazine HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-1548ChlorpromazineChlorpromazine HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent