← FDA DRUG APPROVALS

FDA NDA · NDA216593

XROMI

hydroxyurea

Sponsor: NOVA LABS LTD

APPLICATION
NDA216593
TYPE
NDA
ORIGINAL APPROVAL
2024-04-04
LATEST ACTION
2024-12-23
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

XROMI · ReferencePrescription
HYDROXYUREA 100MG/ML · SOLUTION · ORAL

Approval history

2024-12-23Efficacy · Original · priority — Letter ↗AP
2024-10-18Labeling · Supplement 1 · standard — Letter ↗AP
2024-04-04Type 3 - New Dosage Form · Original · priority — Letter ↗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.

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 →