← FDA Drug Approvals (Drugs@FDA)

XROMI

NDA · New Drug Application · Sponsor: NOVA LABS LTD · Approved 2024-04-04

Drug application

FDA Application #

NDA216593

Application type

New Drug Application

Brand name

XROMI

Generic name

HYDROXYUREA

Active ingredients

HYDROXYUREA

Dosage form

SOLUTION

Route

ORAL

Marketing status

Prescription

Sponsor

NOVA LABS LTD

Manufacturer

Nova Laboratories, Ltd.

First approval

2024-04-04

Source

Authoritative

Drugs@FDA application overview

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