Requests that the FDA declare that the proposed drug products, Gabapentin Powder for Oral Solution, 300 mg/sachet, 400 mg/sachet and 600 mg/sachet are suitable for submission as an ANDA. | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-2258

Requests that the FDA declare that the proposed drug products, Gabapentin Powder for Oral Solution, 300 mg/sachet, 400 mg/sachet and 600 mg/sachet are suitable for submission as an ANDA.

Documents

Comments

Description

Open

Key Dates

Comment Period OpensMar 4, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Completeness Assessment Correspondence	Mar 23, 2026	--

Keywords

CDER

Suitability Petition

Lachman Consulting Services, Inc.

declare

that the proposed drug products

Gabapentin Powder for Oral Solution

300 mg/sachet, 400 mg/sachet

and 600 mg/sachet

Data from Regulations.gov