FDA.reportPublic FDA data

Application 208854

Type
NDA
Sponsor
BDSI

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SYMPROICNALDEMEDINE TOSYLATETABLET;ORALEQ 0.2MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59011-523SymproicnaldemedinePurdue Pharma LPNDACurrent
59011-523SymproicnaldemedinePurdue Pharma LPNDACurrent
59385-041SYMPROICnaldemedine tosylateBioDelivery Sciences International IncNDACurrent
59385-041SYMPROICnaldemedineBioDelivery Sciences International IncNDACurrent
59385-041SYMPROICnaldemedine tosylateBioDelivery Sciences International IncNDACurrent
59385-041SYMPROICnaldemedineBioDelivery Sciences International IncNDACurrent
59385-041SYMPROICnaldemedineBioDelivery Sciences International IncNDACurrent
59385-041SYMPROICnaldemedineBioDelivery Sciences International IncNDACurrent
59385-041SYMPROICnaldemedineBioDelivery Sciences International IncNDACurrent
59630-222SYMPROICnaldemedineShionogi Inc.NDACurrent
59630-222SYMPROICnaldemedineShionogi Inc.NDACurrent
59630-222SYMPROICnaldemedineShionogi Inc.NDACurrent
59630-222SYMPROICnaldemedineShionogi Inc.NDACurrent
59630-222SYMPROICnaldemedineShionogi Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82894SUPPL 2025-07-21
82893SUPPL 2025-07-21
82882SUPPL 2025-07-16
52093SUPPL2018-01-30
51913SUPPL2018-01-26
51911SUPPL2018-01-26
49210SUPPL2017-08-02
49203SUPPL2017-08-02
48241ORIG2017-05-05
47697ORIG2017-03-24
47669ORIG2017-03-24