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HSA Approval

Apo-Sertraline 50mg Tablet

Approval Number

SIN13467P

Drug Name

Apo-Sertraline 50mg Tablet

Product Name

Apo-Sertraline 50mg Tablet

Approval Date

May 15, 2008

Registrant

PHARMAFORTE SINGAPORE PTE LTD

Licence Holder

PHARMAFORTE SINGAPORE PTE LTD

Regulatory Information

Registrant

PHARMAFORTE SINGAPORE PTE LTD

Licence Holder

PHARMAFORTE SINGAPORE PTE LTD

Drug Type

Therapeutic

Forensic Classification

Prescription Only

Formulation Information

Dosage Form

TABLET, FILM COATED

Route of Administration

ORAL

Medical Information

ATC Code

N06AB06

ATC Item Name

sertraline

Manufacturer Information

Pharmaceutical Manufacturer

PHARMAFORTE SINGAPORE PTE LTD

Manufacturers

Apotex Inc.

Active Ingredients

Ingredient Name

Sertraline (equivalent to sertraline hydrochloride 55.9mg)

Strength

50.0 mg

Drug MonographSertraline

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