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HSA Approval

ZADITEN SYRUP 1 mg/5 ml (sugar-free)

Approval Number

SIN07573P

Drug Name

ZADITEN SYRUP 1 mg/5 ml (sugar-free)

Product Name

ZADITEN SYRUP 1 mg/5 ml (sugar-free)

Approval Date

December 15, 1993

Registrant

NOVARTIS (SINGAPORE) PTE LTD

Regulatory Information

Registrant

NOVARTIS (SINGAPORE) PTE LTD

Drug Type

Therapeutic

Forensic Classification

Prescription Only

Formulation Information

Dosage Form

SYRUP

Route of Administration

ORAL

Medical Information

ATC Code

R06AX17

ATC Item Name

ketotifen

Manufacturer Information

Pharmaceutical Manufacturer

NOVARTIS (SINGAPORE) PTE LTD

Manufacturers

DELPHARM HUNINGUE SAS

Active Ingredients

Ingredient Name

KETOTIFEN HYDROGEN FUMARATE EQV KETOTIFEN

Strength

1 mg/5 ml

Drug MonographKetotifen

Documents

Package Inserts

Zaditen_PI.pdf

Approved: July 1, 2016

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