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HSA Approval

VANCOMYCIN POWDER FOR SOLUTION FOR INJECTION/INFUSION 500mg

Approval Number

SIN14527P

Drug Name

VANCOMYCIN POWDER FOR SOLUTION FOR INJECTION/INFUSION 500mg

Product Name

VANCOMYCIN POWDER FOR SOLUTION FOR INJECTION/INFUSION 500mg

Approval Date

March 14, 2014

Registrant

MYLAN PHARMACEUTICALS PTE. LTD.

Licence Holder

MYLAN PHARMACEUTICALS PTE. LTD.

Regulatory Information

Registrant

MYLAN PHARMACEUTICALS PTE. LTD.

Licence Holder

MYLAN PHARMACEUTICALS PTE. LTD.

Drug Type

Therapeutic

Forensic Classification

Prescription Only

Formulation Information

Dosage Form

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Route of Administration

INTRAVENOUS

Medical Information

ATC Code

J01XA01

ATC Item Name

vancomycin

Manufacturer Information

Pharmaceutical Manufacturer

mylan pharmaceuticals pte. ltd.

Manufacturers

Mylan Laboratories Limited [Specialty Formulation Facility]

Active Ingredients

Ingredient Name

VANCOMYCIN HYDROCHLORIDE 512.571 mg/vial EQV VANCOMYCIN

Strength

500 mg/vial

Drug MonographVancomycin

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VANCOMYCIN POWDER FOR SOLUTION FOR INJECTION/INFUSION 500mg - HSA Approval | MedPath