Orange Book product · Brand (NDA)

JAVADIN

CLONIDINE HYDROCHLORIDE

Brand (NDA)NDA 220256RX AZURITY

Oct 23, 2025

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Oct 23, 2025
8 mo ago
Today
Patent 12233049 expires
Listed drug product patent expiration.
Jul 15, 2042
in 16 yr 4 mo
Patent 12440474 expires
Listed drug product patent expiration.
Jul 15, 2042
in 16 yr 4 mo

Active ingredient

CLONIDINE HYDROCHLORIDE

Strength

0.02MG/ML

Dosage form

SOLUTION

Route

ORAL

TE code

Not listed

Application

NDA 220256

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
12233049	Jul 15, 2042	in 16 yr 4 mo	Product
12440474	Jul 15, 2042	in 16 yr 4 mo	Product