FDA.reportPublic FDA data

Application 217645

Type
NDA
Sponsor
TRIS PHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ONYDA XRCLONIDINE HYDROCHLORIDESUSPENSION, EXTENDED RELEASE;ORAL0.1MG/MLYesYes

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82186SUPPL 2025-05-14
82257SUPPL 2025-05-07
80543SUPPL 2024-12-10
80537SUPPL 2024-12-09
79731ORIG 2024-09-25
78564ORIG 2024-05-28
78560ORIG 2024-05-28