Application 218879

Type
NDA
Sponsor
OWP PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SUBVENITELAMOTRIGINESUSPENSION;ORAL10MG/MLYesYes

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84669ORIG 2026-01-06
83377ORIG 2025-09-18
83360ORIG 2025-09-17
83359ORIG 2025-09-16