FDA.reportPublic FDA data

Application 210326

Type
NDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FULVESTRANTFULVESTRANTSOLUTION;INTRAMUSCULAR250MG/5ML (50MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63323-715FulvestrantFulvestrantFresenius Kabi USA, LLCNDACurrent
63323-715FulvestrantFulvestrantFresenius Kabi USA, LLCNDACurrent
63323-715FulvestrantFulvestrantFresenius Kabi USA, LLCNDACurrent
63323-715FulvestrantFulvestrantFresenius Kabi USA, LLCNDACurrent
63323-715FulvestrantFulvestrantFresenius Kabi USA, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67487SUPPL2021-05-13
67486SUPPL2021-05-13
67480SUPPL2021-05-13
67479SUPPL2021-05-13
61776ORIG2020-02-04
54823ORIG2019-10-22
58818ORIG2019-05-21