Siponimod

ANDA 218444, held by Riconpharma LLC. Siponimod.

As of Nov 14, 2026, ANDA 218444 (Siponimod), held by Riconpharma LLC, was first approved by FDA on Apr 22, 2025, with 2 approved supplements and 0 published complete response letters.

First approved: Apr 22, 2025
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Apr 22, 2025	Original application	Approved	None posted

Products

3 strengths and forms


SiponimodEQ 0.25MG BASE · tablet;oral	Siponimod	Discontinued
SiponimodEQ 1MG BASE · tablet;oral	Siponimod	Discontinued
SiponimodEQ 2MG BASE · tablet;oral	Siponimod	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Sep 11, 2026	Supplement 1Labeling · Standard review	Approved	None posted
Sep 11, 2026	Supplement 2Labeling · Standard review	Approved	None posted
Apr 22, 2025	Original application	Approved	None posted

Identifiers

Application: ANDA 218444
Drugs@FDA: Overview at FDA
Company: Riconpharma LLC

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