Rivaroxaban

Lowers the risk of major cardiovascular events. ANDA 213114, held by Macleods Pharms. Rivaroxaban.

As of Nov 13, 2026, ANDA 213114 (Rivaroxaban), held by Macleods Pharms, was first approved by FDA on May 14, 2025, with 0 approved supplements and 0 published complete response letters.

First approved: May 14, 2025
Review: Standard
Supplements approved: 0
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Rivaroxaban tablets are a factor Xa inhibitor indicated:

to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD)
to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD 1.7 Reduction of Risk of Major Cardiovascular Events in Patients with Coronary Artery Disease (CAD) Rivaroxaban tablets, in combination with aspirin, is indicated to reduce the risk of major cardiovascular events (cardiovascular death, myocardial infarction, and stroke) in adult patients with coronary artery disease. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first

Date	Submission	Status	Documents
May 14, 2025	Original application	Approved	None posted

Products

4 strengths and forms

Product	Active ingredient	Marketing
Rivaroxaban2.5MG · tablet;oral	Rivaroxaban	Rx
Rivaroxaban10MG · tablet;oral	Rivaroxaban	Rx
Rivaroxaban15MG · tablet;oral	Rivaroxaban	Rx
Rivaroxaban20MG · tablet;oral	Rivaroxaban	Rx

Identifiers

Application: ANDA 213114
Drugs@FDA: Overview at FDA
Company: Macleods Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters