Lenalidomide

ANDA 209348, held by Dr Reddys. Lenalidomide.

As of Nov 13, 2026, ANDA 209348 (Lenalidomide), held by Dr Reddys, was first approved by FDA on Aug 30, 2022, with 4 approved supplements and 0 published complete response letters.

First approved: Aug 30, 2022
Review: Standard
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

1 IND ICATIONS AND USAGE Lenalidomide is a thalidomide analogue indicated for the treatment of adult patients with:

Multiple myeloma (MM), in combination with dexamethasone.
MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT).
Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities.
Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.
Previously treated follicular lymphoma (FL), in combination with a rituximab product.

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
Aug 30, 2022	Original application	Approved	Letter
Oct 14, 2021	Original application	Approved	REMS Letter

Products

6 strengths and forms

Product	Active ingredient	Marketing
Lenalidomide2.5MG · capsule;oral	Lenalidomide	Rx
Lenalidomide20MG · capsule;oral	Lenalidomide	Rx
Lenalidomide5MG · capsule;oral	Lenalidomide	Rx
Lenalidomide10MG · capsule;oral	Lenalidomide	Rx
Lenalidomide15MG · capsule;oral	Lenalidomide	Rx
Lenalidomide25MG · capsule;oral	Lenalidomide	Rx

All 6 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 27, 2026	Supplement 7REMS	Approved	None posted
Mar 24, 2023	Supplement 4REMS	Approved	None posted
Aug 30, 2022	Original application	Approved	Letter
Jun 30, 2022	Supplement 1REMS	Approved	None posted
Jun 7, 2022	Supplement 2Labeling · Standard review	Approved	None posted
Oct 14, 2021	Original application	Approved	REMS Letter

Identifiers

Application: ANDA 209348
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's Laboratories

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