FDA.reportPublic FDA data

Application 210196

Type
ANDA
Sponsor
AUCTA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VIGADRONEVIGABATRINFOR SOLUTION;ORAL500MG/PACKETNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0245-0556VIGADRONEvigabatrinUpsher-Smith Laboratories, LLCANDACurrent
0245-0556VIGADRONEvigabatrinUpsher-Smith Laboratories, LLCANDACurrent
0245-0556VIGADRONEvigabatrinUpsher-Smith Laboratories, LLCANDACurrent
0245-0556VIGADRONEvigabatrinUpsher-Smith Laboratories, LLCANDACurrent
73289-0002VIGADRONEvigabatrinAucta Pharmaceuticals, Inc.ANDACurrent
73289-0002VIGADRONEvigabatrinAucta Pharmaceuticals, Inc.ANDACurrent
73289-0003VIGADRONEvigabatrinAucta Pharmaceuticals, Inc.ANDACurrent
73289-0003VIGADRONEvigabatrinAucta Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76251ORIG 2023-11-03