← FDA DRUG APPROVALS

FDA ANDA · ANDA212034

CLOFARABINE

Sponsor: ACCORD HLTHCARE

APPLICATION
ANDA212034
TYPE
ANDA
ORIGINAL APPROVAL
2019-02-22
LATEST ACTION
2020-12-14
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

CLOFARABINEPrescription
CLOFARABINE 20MG/20ML (1MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2020-12-14Labeling · Supplement 2 · standardAP
2019-02-22UNKNOWN · Original · standardAP
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 →