FDA.reportPublic FDA data

Application 213553

Type
ANDA
Sponsor
CHEMO RESEARCH SL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FULVESTRANTFULVESTRANTINJECTABLE;INTRAMUSCULAR50MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-070FULVESTRANTfulvestrantNorthstar Rx, LLC,ANDACurrent
16714-070FULVESTRANTfulvestrantNorthstar Rx, LLC,ANDACurrent
70700-284FULVESTRANTfulvestrantXiromed, LLCANDACurrent
70700-284FULVESTRANTfulvestrantXiromed, LLCANDACurrent
70700-284FULVESTRANTfulvestrantXiromed, LLCANDACurrent