FDA.reportPublic FDA data

Application 211150

Type
NDA
Sponsor
HARMONY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001WAKIXPITOLISANT HYDROCHLORIDETABLET;ORALEQ 4.45MG BASEYesNo
002WAKIXPITOLISANT HYDROCHLORIDETABLET;ORALEQ 17.8MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
72028-045WakixPITOLISANT HYDROCHLORIDEHarmony Biosciences, LLCNDACurrent
72028-045WakixPITOLISANT HYDROCHLORIDEHarmony Biosciences, LLCNDACurrent
72028-045WakixPITOLISANT HYDROCHLORIDEHarmony Biosciences, LLCNDACurrent
72028-045WakixPITOLISANT HYDROCHLORIDEHarmony Biosciences, LLCNDACurrent
72028-045WakixPITOLISANT HYDROCHLORIDEHarmony Biosciences, LLCNDACurrent
72028-045WakixPITOLISANT HYDROCHLORIDEHarmony Biosciences, LLCNDACurrent
72028-045WakixPITOLISANT HYDROCHLORIDEHarmony Biosciences, LLCNDACurrent
72028-178WakixPITOLISANT HYDROCHLORIDEHarmony Biosciences, LLCNDACurrent
72028-178WakixPITOLISANT HYDROCHLORIDEHarmony Biosciences, LLCNDACurrent
72028-178WakixPITOLISANT HYDROCHLORIDEHarmony Biosciences, LLCNDACurrent
72028-178WakixPITOLISANT HYDROCHLORIDEHarmony Biosciences, LLCNDACurrent
72028-178WakixPITOLISANT HYDROCHLORIDEHarmony Biosciences, LLCNDACurrent
72028-178WakixPITOLISANT HYDROCHLORIDEHarmony Biosciences, LLCNDACurrent
72028-178WakixPITOLISANT HYDROCHLORIDEHarmony Biosciences, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85058SUPPL 2026-02-18
85053SUPPL 2026-02-18
82397SUPPL 2025-06-02
82336SUPPL 2025-05-28
78881SUPPL 2024-09-03
78876SUPPL 2024-06-24
73040SUPPL2022-12-27
73025SUPPL2022-12-23
67762ORIG2021-06-11
65144ORIG2020-11-03
65137ORIG2020-11-03
64918ORIG2020-10-14
64899ORIG2020-10-14
60095ORIG2019-09-24
59739ORIG2019-08-16
59737ORIG2019-08-16