FDA.reportPublic FDA data

Application 211689

Type
ANDA
Sponsor
ACCORD HLTHCARE

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
16729-436FULVESTRANTFulvestrantAccord Healthcare Inc.ANDACurrent
16729-436FULVESTRANTFulvestrantAccord Healthcare Inc.ANDACurrent
68001-522FULVESTRANTFulvestrantBluePoint LaboratoriesANDACurrent
68001-522FULVESTRANTFulvestrantBluePoint LaboratoriesANDACurrent