Requests that the FDA declare that the drug products Pregabalin Tablets 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg, are suitable for consideration in an Abbreviated New Drug Application (“ANDA”). | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-2430

Requests that the FDA declare that the drug products Pregabalin Tablets 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg, are suitable for consideration in an Abbreviated New Drug Application (“ANDA”).

Documents

Comments

Description

Open

Key Dates

Comment Period OpensMar 9, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Completeness Assessment Correspondence to Hyman, Phelps & McNamara, P.C.	Mar 24, 2026	--

Keywords

Suitability Petition

CDER

HYMAN, PHELPS & MCNAMARA, P.C.

Pregabalin Tablets

25 mg 50 mg 75 mg 100 mg and 150 mg

Approved Drug Products

Therapeutic Equivalence Evaluations

Orange Book

Data from Regulations.gov