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FDA ANDA · ANDA040745

CYCLOPHOSPHAMIDE

Sponsor: BAXTER HLTHCARE

APPLICATION
ANDA040745
TYPE
ANDA
ORIGINAL APPROVAL
2008-05-21
LATEST ACTION
2025-07-11
ROUTE
INTRAVENOUS, ORAL, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

CYCLOPHOSPHAMIDEPrescription
CYCLOPHOSPHAMIDE 2GM/VIAL · INJECTABLE · INJECTION
CYCLOPHOSPHAMIDEPrescription
CYCLOPHOSPHAMIDE 500MG/VIAL · INJECTABLE · INJECTION
CYCLOPHOSPHAMIDEPrescription
CYCLOPHOSPHAMIDE 1GM/VIAL · INJECTABLE · INJECTION

Approval history

2025-07-11Labeling · Supplement 5 · standardAP
2024-03-29Labeling · Supplement 4 · standardAP
2014-10-25Labeling · Supplement 3 · standard — Label ↗AP
2013-06-17Labeling · Supplement 2 · standardAP
2008-05-21Original — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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