Cladribine

ANDA 200510, held by Pharmobedient. Cladribine.

As of Nov 14, 2026, ANDA 200510 (Cladribine), held by Pharmobedient, was first approved by FDA on Oct 6, 2011, with 1 approved supplement and 0 published complete response letters.

First approved: Oct 6, 2011
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Oct 6, 2011	Original application	Approved	None posted

Products

1 strengths and forms

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

All 2 submissions, including labeling and manufacturing supplements


Mar 23, 2023	Supplement 6Labeling · Standard review	Approved	None posted
Oct 6, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 200510
Drugs@FDA: Overview at FDA
Company: PharmoBedient

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