FDA.reportPublic FDA data

Application 207145

Type
NDA
Sponsor
US WORLDMEDS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001XADAGOSAFINAMIDE MESYLATETABLET;ORAL50MGYesNo
002XADAGOSAFINAMIDE MESYLATETABLET;ORAL100MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
27505-110Xadagosafinamide mesylateUS WorldMeds, LLCNDACurrent
27505-110Xadagosafinamide mesylateMDD US Operations, LLCNDACurrent
27505-110Xadagosafinamide mesylateUS WorldMeds, LLCNDACurrent
27505-110Xadagosafinamide mesylateMDD US Operations, LLCNDACurrent
27505-110Xadagosafinamide mesylateMDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc.NDACurrent
27505-110Xadagosafinamide mesylateMDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc.NDACurrent
27505-110Xadagosafinamide mesylateMDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc.NDACurrent
27505-110Xadagosafinamide mesylateUS WorldMeds, LLCNDACurrent
27505-110Xadagosafinamide mesylateUS WorldMeds, LLCNDACurrent
27505-111Xadagosafinamide mesylateUS WorldMeds, LLCNDACurrent
27505-111Xadagosafinamide mesylateMDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc.NDACurrent
27505-111Xadagosafinamide mesylateMDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc.NDACurrent
27505-111Xadagosafinamide mesylateMDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc.NDACurrent
27505-111Xadagosafinamide mesylateMDD US Operations, LLCNDACurrent
27505-111Xadagosafinamide mesylateUS WorldMeds, LLCNDACurrent
27505-111Xadagosafinamide mesylateMDD US Operations, LLCNDACurrent
27505-111Xadagosafinamide mesylateUS WorldMeds, LLCNDACurrent
27505-111Xadagosafinamide mesylateUS WorldMeds, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68325SUPPL2021-08-10
68316SUPPL2021-08-09
61100SUPPL2019-11-29
61081SUPPL2019-11-27
48775SUPPL2017-06-20
48756SUPPL2017-06-19
48180ORIG2017-05-01
47730ORIG2017-03-28
47630ORIG2017-03-22