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HSA Approval

Suboxone 8 mg/2 mg sublingual tablets

Approval Number

SIN13405P

Drug Name

Suboxone 8 mg/2 mg sublingual tablets

Product Name

Suboxone 8 mg/2 mg sublingual tablets

Approval Date

January 28, 2008

Registrant

ZUELLIG PHARMA PTE. LTD.

Regulatory Information

Registrant

ZUELLIG PHARMA PTE. LTD.

Drug Type

Therapeutic

Forensic Classification

Prescription Only

Formulation Information

Dosage Form

TABLET, ORALLY DISINTEGRATING

Route of Administration

SUBLINGUAL

Medical Information

ATC Code

N02AE01

ATC Item Name

buprenorphine

Manufacturer Information

Pharmaceutical Manufacturer

ZUELLIG PHARMA PTE. LTD.

Manufacturers

RECKITT BENCKISER HEALTHCARE (UK) LTD

Active Ingredients

Ingredient Name

BUPRENORPHINE HCL

Strength

8.64MG

Drug MonographBuprenorphine

Ingredient Name

NALOXONE HCL

Strength

2.44MG

Drug MonographNaloxone

Documents

Package Inserts

Suboxone Tablet PI.pdf

Approved: October 27, 2016

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Suboxone 8 mg/2 mg sublingual tablets - HSA Approval | MedPath