← FDA DRUG APPROVALS

FDA ANDA · ANDA201784

CYTARABINE

Sponsor: RISING

APPLICATION
ANDA201784
TYPE
ANDA
ORIGINAL APPROVAL
2012-01-30
LATEST ACTION
2024-12-11
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

CYTARABINEPrescription
CYTARABINE 100MG/ML · INJECTABLE · INJECTION

Approval history

2024-12-11Labeling · Supplement 7 · standardAP
2024-12-11Labeling · Supplement 4 · standardAP
2012-01-30Not Applicable · OriginalReviewAP
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 →