Requests that the FDA confirm that Benazepril Hydrochloride and Hydrochlorothiazide Powder for Oral Suspension is suitable for submission in an Abbreviated New Drug Application. | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2025-P-7284

Requests that the FDA confirm that Benazepril Hydrochloride and Hydrochlorothiazide Powder for Oral Suspension is suitable for submission in an Abbreviated New Drug Application.

Documents

Comments

Description

CLOSED

Key Dates

Comment Period OpensDec 22, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Final Response Letter from FDA CDER to Premier Research International, LLC	May 26, 2026	--

Keywords

CDER

Suitability Petition

Premier Research International, LLC

confirm that Benazepril Hydrochloride

Hydrochlorothiazide Powder

for Oral Suspension is suitable for submission

in an Abbreviated New Drug Application

CLOSED

Data from Regulations.gov