APPLICATION
ANDA211757
TYPE
ANDA
ORIGINAL APPROVAL
2022-10-18
LATEST ACTION
2022-10-18
ROUTE
INTRAVENOUS, ORAL, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
CYCLOPHOSPHAMIDEPrescription
CYCLOPHOSPHAMIDE 1GM/VIAL · INJECTABLE · INJECTION
CYCLOPHOSPHAMIDEPrescription
CYCLOPHOSPHAMIDE 2GM/VIAL · INJECTABLE · INJECTION
CYCLOPHOSPHAMIDEPrescription
CYCLOPHOSPHAMIDE 500MG/VIAL · INJECTABLE · INJECTION
Approval history
2022-10-18UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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