Leustatin

NDA 20229, held by Janssen Pharms. Cladribine.

As of Nov 13, 2026, NDA 20229 (Leustatin), held by Janssen Pharms, was first approved by FDA on Feb 26, 1993, with 5 approved supplements and 0 published complete response letters.

First approved: Feb 26, 1993
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Feb 26, 1993	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Leustatin1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Cladribine	DiscontinuedReference drug

All 6 submissions, including labeling and manufacturing supplements


Aug 2, 2012	Supplement 34Labeling · Standard review	Approved	Label Letter
Jun 29, 2006	Supplement 30Labeling · Standard review	Approved	Letter
Aug 22, 2002	Supplement 21Labeling · Standard review	Approved	Letter
Aug 20, 2002	Supplement 4Labeling · Standard review	Approved	Letter
Aug 20, 2002	Supplement 7Labeling · Standard review	Approved	Letter
Feb 26, 1993	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 20229
Drugs@FDA: Overview at FDA
Company: Janssen Pharmaceuticals, Inc.

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