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HSA Approval

INDRONATE FILM-COATED TABLET 35 MG

Approval Number

SIN14439P

Drug Name

INDRONATE FILM-COATED TABLET 35 MG

Product Name

INDRONATE FILM-COATED TABLET 35 MG

Approval Date

November 14, 2013

Registrant

INTEGA PTE LTD

Licence Holder

INTEGA PTE LTD

Regulatory Information

Registrant

INTEGA PTE LTD

Licence Holder

INTEGA PTE LTD

Drug Type

Therapeutic

Forensic Classification

Prescription Only

Formulation Information

Dosage Form

TABLET, FILM COATED

Route of Administration

ORAL

Medical Information

ATC Code

M05BA07

ATC Item Name

risedronic acid

Manufacturer Information

Pharmaceutical Manufacturer

INTEGA PTE. LTD.

Manufacturers

Pharmathen S.A.

Pharmathen International S.A.

Active Ingredients

Ingredient Name

Risedronate sodium hemipentahydrate 40.17mg equiv. to Risedronate sodium

Strength

35mg

Drug MonographRisedronic acid

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