FDA.reportPublic FDA data

Application 206426

Type
NDA
Sponsor
BIOCRYST

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RAPIVABPERAMIVIRSOLUTION;INTRAVENOUS200MG/20ML (10MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61364-181RapivabperamivirSeqirus USA Inc.NDACurrent
61364-181RapivabperamivirSeqirus USA Inc.NDACurrent
72769-181RapivabperamivirBioCryst Pharmaceuticals, Inc.NDACurrent
72769-181RapivabperamivirBioCryst Pharmaceuticals, Inc.NDACurrent
72769-181RapivabperamivirBioCryst Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78802SUPPL 2024-06-14
78799SUPPL 2024-06-14
66042SUPPL2021-02-01
66020SUPPL2021-01-29
54041SUPPL2018-05-08
54021SUPPL2018-05-04
49836SUPPL2017-09-22
49832SUPPL2017-09-22
45074SUPPL2016-08-17
45125SUPPL2016-08-12
44945ORIG2015-01-16
43520ORIG2015-01-16
40548ORIG2015-01-08
32808ORIG2014-12-23
53543SUPPL1900-01-01
51547SUPPL1900-01-01
51546SUPPL1900-01-01