Requests that the FDA issue a declaration permitting the submission of an Abbreviated New Drug Application for Gabapentin Capsules, 150 mg. | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-5123

Requests that the FDA issue a declaration permitting the submission of an Abbreviated New Drug Application for Gabapentin Capsules, 150 mg.

Documents

Comments

Key Dates

Comment Period OpensMay 8, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Suitability Petition Amendment from Rising Pharma Holdings, Inc.	Jun 5, 2026	--

Keywords

CDER

Suitability Petition

Rising Pharma Holdings Inc

issue a

declaration permitting the submission of an

Abbreviated New Drug Application

for Gabapentin Capsules 150 mg

OPEN

Data from Regulations.gov