FDA.reportPublic FDA data

Application 079242

Type
ANDA
Sponsor
FRESENIUS KABI USA

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
63323-273Sumatriptan SuccinateSumatriptan SuccinateFresenius Kabi USA, LLCANDACurrent
63323-273Sumatriptan SuccinateSumatriptan SuccinateFresenius Kabi USA, LLCANDACurrent
63323-273Sumatriptan SuccinateSumatriptan SuccinateFresenius Kabi USA, LLCANDACurrent
63323-273Sumatriptan SuccinateSumatriptan SuccinateFresenius Kabi USA, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18495ORIG2009-03-02