FDA.reportPublic FDA data

Application 210884

Type
NDA
Sponsor
UPSHER SMITH LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TOSYMRASUMATRIPTANSPRAY;NASAL10MG/SPRAYYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0245-0812TOSYMRAsumatriptanUpsher-Smith Laboratories, LLCNDACurrent
0245-0812TOSYMRAsumatriptanUpsher-Smith Laboratories, LLCNDACurrent
67857-812TOSYMRAsumatriptanPromius Pharma, LLC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59999ORIG2019-09-13
57549ORIG2019-02-13
57387ORIG2019-01-30