Requests that the FDA declare that the proposed drug products, Rivaroxaban ODT, 2.5 mg, 10 mg, 15 mg and 20 mg are suitable for submission as an ANDA. The listed reference drug product (RLD), upon which this petition is based, is XARELTO® Tablets, 2.5 mg, 10 mg, 15 mg and 20 mg by Janssen Pharmaceuticals, Inc., NDA #022406. | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-1794

Requests that the FDA declare that the proposed drug products, Rivaroxaban ODT, 2.5 mg, 10 mg, 15 mg and 20 mg are suitable for submission as an ANDA. The listed reference drug product (RLD), upon which this petition is based, is XARELTO® Tablets, 2.5 mg, 10 mg, 15 mg and 20 mg by Janssen Pharmaceuticals, Inc., NDA #022406.

Documents

Comments

Description

OPEN

Key Dates

Comment Period OpensFeb 18, 2026

Documents

Type	Title	Posted	Comments	Status
Other	Completeness Assessment Correspondence	Mar 10, 2026	--

Keywords

CDER

Suitability Petition

Rivaroxaban ODT, 2.5 mg, 10 mg, 15 mg

declare that the proposed drug products

and 20 mg are suitable for submission

as an ANDA. The listed reference drug

product (RLD), upon which this petition is based

, is XARELTO Tablets, 2.5 mg, 10 mg,

Data from Regulations.gov