Orange Book product · Brand (NDA)

XROMI

HYDROXYUREA

Brand (NDA)NDA 216593RX NOVA LABS LTD

Apr 04, 2024

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Apr 04, 2024
2 yr 3 mo ago
Today
Exclusivity ends · NP
New product exclusivity (3 years)
Apr 04, 2027
in 10 mo
Exclusivity ends · ODE-470
Orphan-drug exclusivity (7 years)
Apr 04, 2031
in 4 yr 10 mo
Patent 12409156 expires
Listed drug product patent expiration.
Dec 23, 2041
in 15 yr 9 mo

Active ingredient

HYDROXYUREA

Strength

100MG/ML

Dosage form

SOLUTION

Route

ORAL

TE code

Not listed

Application

NDA 216593

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
12409156	Dec 23, 2041	in 15 yr 9 mo	Product