FDA.reportPublic FDA data

Application 210044

Type
ANDA
Sponsor
AMNEAL

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
68001-484FulvestrantFulvestrantBluePoint LaboratoriesANDACurrent
70121-1463FulvestrantFulvestrantAmneal Pharmaceuticals LLCANDACurrent
70121-1463FulvestrantFulvestrantAmneal Pharmaceuticals LLCANDACurrent
70121-1463FulvestrantFulvestrantAmneal Pharmaceuticals LLCANDACurrent
70121-1463FulvestrantFulvestrantAmneal Biosciences LLCANDACurrent
70121-1463FulvestrantFulvestrantAmneal Pharmaceuticals LLCANDACurrent
70121-1463FulvestrantFulvestrantAmneal Pharmaceuticals LLCANDACurrent
70121-1463FulvestrantFulvestrantAmneal Pharmaceuticals LLCANDACurrent
70121-1463FulvestrantFulvestrantAmneal Pharmaceuticals LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
58424ORIG2019-04-26