FDA.reportPublic FDA data

Application 206962

Type
ANDA
Sponsor
NOVAST LABS

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
50742-404TopotecanTopotecanIngenus Pharmaceuticals, LLCANDACurrent
50742-404TopotecanTopotecanIngenus Pharmaceuticals, LLCANDACurrent
50742-404TopotecanTopotecanIngenus Pharmaceuticals, LLCANDACurrent