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HSA Approval

GRALISE EXTENDED RELEASE TABLETS 600 MG

SIN17165P

GRALISE EXTENDED RELEASE TABLETS 600 MG

GRALISE EXTENDED RELEASE TABLETS 600 MG

January 16, 2025

LOTUS INTERNATIONAL PTE. LTD.

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

Gabapentin

600.00 mg

Gabapentin

Documents

Package Inserts

Gralise PI.pdf

Approved: January 16, 2025

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GRALISE EXTENDED RELEASE TABLETS 600 MG - HSA Approval | MedPath