Application 204406

Type
ANDA
Sponsor
ACCORD HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOPOTECAN HYDROCHLORIDETOPOTECAN HYDROCHLORIDESOLUTION;INTRAVENOUSEQ 1MG BASE/ML (EQ 1MG BASE/ML)NoNo
002TOPOTECAN HYDROCHLORIDETOPOTECAN HYDROCHLORIDESOLUTION;INTRAVENOUSEQ 4MG BASE/4ML (EQ 1MG BASE/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16729-243TopotecanTopotecanAccord Healthcare Inc.ANDACurrent
16729-243TopotecanTopotecanAccord Healthcare Inc.ANDACurrent