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HSA Approval

FLUDARABINE PHOSPHATE POWDER FOR SOLUTION FOR INJECTION/ INFUSION USP

SIN15030P

FLUDARABINE PHOSPHATE POWDER FOR SOLUTION FOR INJECTION/ INFUSION USP

FLUDARABINE PHOSPHATE POWDER FOR SOLUTION FOR INJECTION/ INFUSION USP

June 8, 2016

FRESENIUS KABI (SINGAPORE) PTE LTD

FRESENIUS KABI (SINGAPORE) PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantFRESENIUS KABI (SINGAPORE) PTE LTD
Licence HolderFRESENIUS KABI (SINGAPORE) PTE LTD

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

INJECTION, POWDER, FOR SOLUTION

INTRAVENOUS

Medical Information

L01BB05

fludarabine

Manufacturer Information

FRESENIUS KABI (SINGAPORE) PTE LTD

Fresenius Kabi Oncology Limited

Active Ingredients

Fludarabine Phosphate USP

50 mg/ vial

Fludarabine

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