Application 219666

Type
NDA
Sponsor
PTC THERAP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SEPHIENCESEPIAPTERINPOWDER;ORAL250MG/PACKETYesNo
002SEPHIENCESEPIAPTERINPOWDER;ORAL1GM/PACKETYesYes

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83247ORIG 2025-09-02
82983ORIG 2025-07-29
82972ORIG 2025-07-29