Request that the FDA declare that the BELSOMRA® (Suvorexant) Tablets 5 mg, 10 mg, 15 mg and 20 mg, approved under NDA # 204569 is suitable for submission as an abbreviated new drug application (ANDA) | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-1300

Request that the FDA declare that the BELSOMRA® (Suvorexant) Tablets 5 mg, 10 mg, 15 mg and 20 mg, approved under NDA # 204569 is suitable for submission as an abbreviated new drug application (ANDA)

Documents

Comments

Description

OPEN

Key Dates

Comment Period OpensFeb 5, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Completeness Assessment Correspondence to APDM Pharmaceuticals Private Limited	Mar 5, 2026	--

Keywords

CDER

Suitability Petition

APDM Pharmaceuticals Private Limited

BELSOMRA (Suvorexant) Tablets

5 mg, 10 mg, 15 mg and 20 mg

suitable for submission

as an abbreviated new drug application (ANDA)

reference listed drug product (RLD)

Data from Regulations.gov