Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
RegistrantLOTUS INTERNATIONAL PTE. LTD.
Product Classification
D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification
Formulation Information
TABLET, EXTENDED RELEASE
ORAL
Medical Information
N02BF01
Manufacturer Information
LOTUS INTERNATIONAL PTE. LTD.
Norwich Pharmaceuticals, Inc.
Active Ingredients
Documents
Package Inserts
Gralise PI.pdf
Approved: January 16, 2025