Lenalidomide

ANDA 213165, held by Cipla. Lenalidomide.

As of Nov 13, 2026, ANDA 213165 (Lenalidomide), held by Cipla, was first approved by FDA on Feb 2, 2026, with 1 approved supplement and 0 published complete response letters.

First approved: Feb 2, 2026
Review: Standard
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
Feb 2, 2026	Original application	Approved	None posted

Products

5 strengths and forms

Product	Active ingredient	Marketing
Lenalidomide5MG · capsule;oral	Lenalidomide	Rx
Lenalidomide10MG · capsule;oral	Lenalidomide	Rx
Lenalidomide15MG · capsule;oral	Lenalidomide	Rx
Lenalidomide20MG · capsule;oral	Lenalidomide	Rx
Lenalidomide25MG · capsule;oral	Lenalidomide	Rx

All 2 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 27, 2026	Supplement 2REMS	Approved	None posted
Feb 2, 2026	Original application	Approved	None posted

Identifiers

Application: ANDA 213165
Drugs@FDA: Overview at FDA
Company: Cipla

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