FDA.reportPublic FDA data

Application 090620

Type
ANDA
Sponsor
ACTAVIS TOTOWA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOPOTECAN HYDROCHLORIDETOPOTECAN HYDROCHLORIDEINJECTABLE;INJECTIONEQ 4MG BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45963-615Topotecan hydrochlorideTopotecan hydrochlorideActavis Pharma, Inc.ANDACurrent
45963-615Topotecan hydrochlorideTopotecan hydrochlorideActavis Pharma, Inc.ANDACurrent
45963-615Topotecan hydrochlorideTopotecan hydrochlorideActavis Pharma, Inc.ANDACurrent
45963-615Topotecan hydrochlorideTopotecan hydrochlorideActavis Pharma, Inc.ANDACurrent