Cladribine

ANDA 75405, held by Hikma. Cladribine.

As of Nov 14, 2026, ANDA 75405 (Cladribine), held by Hikma, was first approved by FDA on Feb 28, 2000, with 5 approved supplements and 0 published complete response letters.

First approved: Feb 28, 2000
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Cladribine Injection, USP is indicated for the treatment of active Hairy Cell Leukemia as defined by clinically significant anemia, neutropenia, thrombocytopenia or disease-related symptoms.

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
Feb 28, 2000	Original application	Approved	Letter Review Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Cladribine1MG/ML · injectable;injection	Cladribine	Rx

All 6 submissions, including labeling and manufacturing supplements


Jan 8, 2013	Supplement 9Labeling · Standard review	Approved	None posted
Feb 7, 2007	Supplement 6Labeling	Approved	None posted
Apr 3, 2001	Supplement 3Manufacturing	Approved	None posted
Nov 3, 2000	Supplement 2Labeling	Approved	None posted
Nov 3, 2000	Supplement 1Manufacturing	Approved	None posted
Feb 28, 2000	Original application	Approved	Letter Review Letter

Identifiers

Application: ANDA 75405
Drugs@FDA: Overview at FDA
Company: Hikma

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