Requests that the FDA declare that the proposed drug products, Pregabalin Extended-Release Tablets, 247.5 mg, 495 mg and 660 mg, are suitable for submission as an ANDA | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-1792

Requests that the FDA declare that the proposed drug products, Pregabalin Extended-Release Tablets, 247.5 mg, 495 mg and 660 mg, are suitable for submission as an ANDA

Documents

Comments

Description

Open

Key Dates

Comment Period OpensFeb 19, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Completeness Assessment Correspondence	Mar 9, 2026	--

Keywords

CDER

Suitability Petition

PharmaVector LLC

Requests that the FDA declare that the

proposed drug products

Pregabalin Extended-Release Tablets

247.5 mg, 495 mg and 660 mg, are

suitable for submission as an ANDA

Data from Regulations.gov