FDA.reportPublic FDA data

Application 205095

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RUFINAMIDERUFINAMIDETABLET;ORAL200MGNoNo
002RUFINAMIDERUFINAMIDETABLET;ORAL400MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-2330RufinamiderufinamideMylan Pharmaceuticals Inc.ANDACurrent
0378-2330RufinamiderufinamideMylan Pharmaceuticals Inc.ANDACurrent
0378-2330RufinamiderufinamideMylan Pharmaceuticals Inc.ANDACurrent
0378-2330RufinamiderufinamideMylan Pharmaceuticals Inc.ANDACurrent
0378-2331RufinamiderufinamideMylan Pharmaceuticals Inc.ANDACurrent
0378-2331RufinamiderufinamideMylan Pharmaceuticals Inc.ANDACurrent
0378-2331RufinamiderufinamideMylan Pharmaceuticals Inc.ANDACurrent
0378-2331RufinamiderufinamideMylan Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
19622ORIG2016-05-20
32628ORIG2016-05-18