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Active ingredient

Lenalidomide

114 finished FDA listings contain Lenalidomide as their only active ingredient.

FDA NDC Directory

Ingredient names as written by FDA
LENALIDOMIDE
Dosage forms
Capsule
Routes
Oral
Manufacturers / labelers
19
Strengths listed
10 mg/1 · 15 mg/1 · 2.5 mg/1 · 20 mg/1 · 25 mg/1 · 5 mg/1
Brand names in FDA listings
Revlimid

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 342369

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
NDA 021880BRISTOL MYERS SQUIBB2005-12-276
ANDA 201452ARROW INTL2021-05-216
ANDA 209348DR REDDYS2021-10-146
ANDA 213912MYLAN2022-08-306
ANDA 211022APOTEX2022-08-306
ANDA 210480ALVOGEN2022-08-316
ANDA 210435CIPLA2022-09-0610
ANDA 210154ZYDUS PHARMS2022-09-1212
ANDA 211846SUN PHARM2023-02-086
ANDA 214618CIPLA2023-03-062
ANDA 213885EUGIA PHARMA2023-03-066
ANDA 212414HETERO LABS LTD V2023-05-116
ANDA 217265QILU2024-02-226
ANDA 217281NOVUGEN2024-09-116
ANDA 216213AMNEAL2025-01-316
ANDA 215759BIOCON PHARMA2025-03-036
ANDA 217554DEVA HOLDING AS2025-05-226
ANDA 218872ACCORD HLTHCARE2025-11-146

Official labeling on DailyMed

Showing the 12 most recent of 20 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.