FDA.reportPublic FDA data

Application 202351

Type
ANDA
Sponsor
ACCORD HLTHCARE

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
16729-151topotecan hydrochloridetopotecan hydrochlorideAccord Healthcare, Inc.ANDACurrent
16729-151topotecan hydrochloridetopotecan hydrochlorideAccord Healthcare, Inc.ANDACurrent
16729-151topotecan hydrochloridetopotecan hydrochlorideAccord Healthcare, Inc.ANDACurrent
16729-151topotecan hydrochloridetopotecan hydrochlorideAccord Healthcare, Inc.ANDACurrent