Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214618
Company: CIPLA

• REMS

Products on ANDA 214618

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LENALIDOMIDE	LENALIDOMIDE	2.5MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214618

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/06/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/24/2023	SUPPL-1	REMS - MODIFIED - D-N-A		Label is not available on this site.

Therapeutic Equivalents for ANDA 214618

LENALIDOMIDE

CAPSULE;ORAL; 2.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LENALIDOMIDE	LENALIDOMIDE	2.5MG	CAPSULE;ORAL	Prescription	No	AB	218872	ACCORD HLTHCARE
LENALIDOMIDE	LENALIDOMIDE	2.5MG	CAPSULE;ORAL	Prescription	No	AB	210480	ALVOGEN
LENALIDOMIDE	LENALIDOMIDE	2.5MG	CAPSULE;ORAL	Prescription	No	AB	216213	AMNEAL
LENALIDOMIDE	LENALIDOMIDE	2.5MG	CAPSULE;ORAL	Prescription	No	AB	211022	APOTEX
LENALIDOMIDE	LENALIDOMIDE	2.5MG	CAPSULE;ORAL	Prescription	No	AB	201452	ARROW INTL
LENALIDOMIDE	LENALIDOMIDE	2.5MG	CAPSULE;ORAL	Prescription	No	AB	215759	BIOCON PHARMA
LENALIDOMIDE	LENALIDOMIDE	2.5MG	CAPSULE;ORAL	Prescription	No	AB	214618	CIPLA
LENALIDOMIDE	LENALIDOMIDE	2.5MG	CAPSULE;ORAL	Prescription	No	AB	217554	DEVA HOLDING AS
LENALIDOMIDE	LENALIDOMIDE	2.5MG	CAPSULE;ORAL	Prescription	No	AB	209348	DR REDDYS
LENALIDOMIDE	LENALIDOMIDE	2.5MG	CAPSULE;ORAL	Prescription	No	AB	213885	EUGIA PHARMA
LENALIDOMIDE	LENALIDOMIDE	2.5MG	CAPSULE;ORAL	Prescription	No	AB	212414	HETERO LABS LTD V
LENALIDOMIDE	LENALIDOMIDE	2.5MG	CAPSULE;ORAL	Prescription	No	AB	214398	LUPIN LTD
LENALIDOMIDE	LENALIDOMIDE	2.5MG	CAPSULE;ORAL	Prescription	No	AB	213912	MYLAN
LENALIDOMIDE	LENALIDOMIDE	2.5MG	CAPSULE;ORAL	Prescription	No	AB	217281	NOVUGEN
LENALIDOMIDE	LENALIDOMIDE	2.5MG	CAPSULE;ORAL	Prescription	No	AB	217265	QILU
LENALIDOMIDE	LENALIDOMIDE	2.5MG	CAPSULE;ORAL	Prescription	No	AB	211846	SUN PHARM
LENALIDOMIDE	LENALIDOMIDE	2.5MG	CAPSULE;ORAL	Prescription	No	AB	210154	ZYDUS PHARMS
REVLIMID	LENALIDOMIDE	2.5MG	CAPSULE;ORAL	Prescription	Yes	AB	021880	BRISTOL MYERS SQUIBB