FDA.reportPublic FDA data

Application 205579

Type
NDA
Sponsor
EAGLE PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RYANODEXDANTROLENE SODIUMFOR SUSPENSION;INTRAVENOUS250MG/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42367-540RYANODEXdantrolene sodiumEagle Pharmaceuticals, Inc.NDACurrent
42367-540RYANODEXdantrolene sodiumEagle Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78048SUPPL 2024-04-03
78040SUPPL 2024-04-03
64465SUPPL2020-09-01
64414SUPPL2020-08-26
44922ORIG2016-03-23
43494ORIG2016-03-23
40483ORIG2014-07-24
10467ORIG2014-07-24