Application 215559

Type
NDA
Sponsor
IPSEN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SOHONOSPALOVAROTENECAPSULE;ORAL1MGYesNo
002SOHONOSPALOVAROTENECAPSULE;ORAL1.5MGYesNo
003SOHONOSPALOVAROTENECAPSULE;ORAL2.5MGYesNo
004SOHONOSPALOVAROTENECAPSULE;ORAL5MGYesNo
005SOHONOSPALOVAROTENECAPSULE;ORAL10MGYesYes

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81607SUPPL 2025-03-17
81596SUPPL 2025-03-17
81595SUPPL 2025-03-17
75489ORIG 2023-09-15
75111ORIG 2023-08-17
75108ORIG 2023-08-17