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GRAFAPEX (NDA214759)- (1GM/VIAL,5GM/VIAL)

TREOSULFAN MEDEXUS
1GM/VIAL,5GM/VIAL
No No
2025-Oct-12 2030-Jan-21
None None
None No
GRAFAPEX is an alkylating drug indicated for: • Use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult and pediatric patients 1 year of age and older with acute myeloid leukemia (AML). • Use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age and older with myelodysplastic syndrome (MDS).
0 0 0
Total Other Developers None
Drugs with Suitability No
1GM/VIAL ** ** - - -
5GM/VIAL ** ** - - -
NDA Sales Available Total Generic Sales Available
No 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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Brand Name Generic Name Strength Dosage Route of Administration Innovator ParaIV

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