Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
RegistrantA. MENARINI SINGAPORE PTE. LTD.
Product Classification
D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification
Formulation Information
TABLET, FILM COATED
ORAL
Medical Information
L02BA04
Manufacturer Information
A. MENARINI SINGAPORE PTE. LTD.
CATALENT GREENVILLE, INC.
Active Ingredients
Documents
Package Inserts
Orserdu film coated Tablet PI.pdf
Approved: September 25, 2024