FDA.reportPublic FDA data

Application 208223

Type
NDA
Sponsor
UPSHER SMITH LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZEMBRACE SYMTOUCHSUMATRIPTAN SUCCINATESOLUTION;SUBCUTANEOUSEQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0245-0809ZEMBRACE SYMTOUCHSumatriptan SuccinateUpsher-Smith laboratories, LLCNDACurrent
0245-0809ZEMBRACE SYMTOUCHSumatriptan SuccinateUpsher-Smith laboratories, LLCNDACurrent
0245-0809ZEMBRACE SYMTOUCHSumatriptan SuccinateUpsher-Smith laboratories, LLCNDACurrent
67857-809ZEMBRACE SymTouchsumatriptanPromius Pharma, LLCNDACurrent
67857-809ZEMBRACE SymTouchsumatriptanPromius Pharma, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59014SUPPL2019-06-12
59011SUPPL2019-06-11
50197ORIG2017-10-26
47692SUPPL2017-03-28
47626SUPPL2017-03-28
40627ORIG2016-02-11
32899ORIG2016-02-01