Requests that the FDA issue a declaration permitting the submission of an Abbreviated New Drug Application (ANDA) for Trazodone Hydrochloride Tablets, USP 200 mg strength | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-4853

Requests that the FDA issue a declaration permitting the submission of an Abbreviated New Drug Application (ANDA) for Trazodone Hydrochloride Tablets, USP 200 mg strength

Documents

Comments

Description

Open

Key Dates

Comment Period OpensMay 5, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Completeness Assessment Correspondence	Jun 17, 2026	--

Keywords

CDER

Suitability Petition

Graviti Pharmaceuticals Private Limited

Requests that the FDA issue a declaration

permitting the submission of an

Abbreviated New Drug Application (ANDA) for

Trazodone Hydrochloride Tablets,

USP 200 mg strength

Data from Regulations.gov