FDA.reportPublic FDA data

Application 213998

Type
ANDA
Sponsor
CAPLIN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATEINJECTABLE;SUBCUTANEOUSEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65145-118SumatriptanSumatriptanCaplin Steriles LimitedANDACurrent
70069-804SumatriptanSumatriptanSomerset Therapeutics, LLCANDACurrent
70594-068SumatriptanSUMATRIPTAN SUCCINATEXellia Pharmaceuticals USA LLCANDACurrent