Lenalidomide

ANDA 212414, held by Hetero Labs Ltd V. Lenalidomide.

As of Nov 13, 2026, ANDA 212414 (Lenalidomide), held by Hetero Labs Ltd V, was first approved by FDA on May 11, 2023, with 1 approved supplement and 0 published complete response letters.

First approved: May 11, 2023
Review: Standard
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications 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 2 submissions below

Date	Submission	Status	Documents
May 11, 2023	Original application	Approved	REMS

Products

6 strengths and forms

Product	Active ingredient	Marketing
Lenalidomide2.5MG · capsule;oral	Lenalidomide	Rx
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 3REMS	Approved	None posted
May 11, 2023	Original application	Approved	REMS

Identifiers

Application: ANDA 212414
Drugs@FDA: Overview at FDA
Company: Hetero Labs Ltd

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