Request that the FDA determine and declare that Gabapentin Tablets 150 mg is suitable for submission in an Abbreviated New Drug Application (ANDA) | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-5611

Request that the FDA determine and declare that Gabapentin Tablets 150 mg is suitable for submission in an Abbreviated New Drug Application (ANDA)

Documents

Comments

Description

OPEN

Key Dates

Comment Period OpensMay 14, 2026

Documents

Type	Title	Posted	Comments	Status
Supporting Material	attachment-3-test-product-draft-labeling	May 14, 2026	--

Keywords

CDER

Suitability Petition

Senores Pharmaceuticals, Inc

determine and declare that Gabapentin Tablets

150 mg is suitable for submission in an

Abbreviated New Drug Application (ANDA)

OPEN

Data from Regulations.gov