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

Documents

Comments

Key Dates

Comment Period OpensDec 22, 2025

Type	Title	Posted	Comments	Status
Other	Final Response Letter from FDA CDER to Premier Research International, LLC	May 22, 2026	--

CDER

Suitability Petition

Premier Research International, LLC

confirm that Lisinopril and

Hydrochlorothiazide Powder for

for Oral Suspension is suitable for submission

in an Abbreviated New Drug Application

OPEN