← FDA DRUG APPROVALS

FDA ANDA · ANDA204555

CYCLOPHOSPHAMIDE

Sponsor: HENGRUI PHARMA

APPLICATION
ANDA204555
TYPE
ANDA
ORIGINAL APPROVAL
2014-10-31
LATEST ACTION
2014-10-31
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

2014-10-31UNKNOWN · OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →