Fingolimod Hydrochloride

Treats relapsing forms of multiple sclerosis (MS). ANDA 208004, held by Alkem Labs Ltd. Fingolimod Hydrochloride.

As of Nov 15, 2026, ANDA 208004 (Fingolimod Hydrochloride), held by Alkem Labs Ltd, was first approved by FDA on Dec 30, 2020, with 3 approved supplements and 0 published complete response letters.

First approved: Dec 30, 2020
Review: Standard
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Dec 30, 2020	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Fingolimod HydrochlorideEQ 0.5MG BASE · capsule;oral	Fingolimod Hydrochloride	Rx

All 4 submissions, including labeling and manufacturing supplements


Sep 25, 2026	Supplement 9Labeling · Standard review	Approved	None posted
Feb 19, 2025	Supplement 7Labeling · Standard review	Approved	None posted
May 30, 2024	Supplement 4Labeling · Standard review	Approved	None posted
Dec 30, 2020	Original application	Approved	None posted

Identifiers

Application: ANDA 208004
Drugs@FDA: Overview at FDA
Company: Alkem Laboratories

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