FDA.reportPublic FDA data

Application 206099

Type
NDA
Sponsor
CURRAX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ONZETRA XSAILSUMATRIPTAN SUCCINATEPOWDER;NASALEQ 11MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42847-311Onzetra Xsailsumatriptan succinateCurrax Pharmaceuticals LLCNDACurrent
42847-311Onzetra Xsailsumatriptan succinateCurrax Pharmaceuticals LLCNDACurrent
42847-311Onzetra Xsailsumatriptan succinateCurrax Pharmaceuticals LLCNDACurrent
64597-311ONZETRAsumatriptan succinateAvanir Pharmaceuticals, Inc.NDACurrent
64597-311ONZETRAsumatriptan succinateAvanir Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61445SUPPL2019-12-26
61394SUPPL2019-12-23
59132SUPPL2019-06-20
59121SUPPL2019-06-19
23012ORIG2016-07-19
19705ORIG2016-02-18
10545ORIG2016-01-29