Orange Book product · Brand (NDA)

INZIRQO

HYDROCHLOROTHIAZIDE

Brand (NDA)NDA 219141RX NOVITIUM PHARMA

Jan 28, 2025

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jan 28, 2025
1 yr 5 mo ago
Today
Patent 11878022 expires
Listed drug product patent expiration.
Jan 23, 2044
in 17 yr 10 mo
Patent 11878022 expires
Listed drug product patent expiration.
Jan 23, 2044
in 17 yr 10 mo

Active ingredient

HYDROCHLOROTHIAZIDE

Strength

10MG/ML

Dosage form

FOR SUSPENSION

Route

ORAL

TE code

Not listed

Application

NDA 219141

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
11878022	Jan 23, 2044	in 17 yr 10 mo	ProductU-4138
11878022	Jan 23, 2044	in 17 yr 10 mo	ProductU-4139