Application 210435

Type: ANDA
Sponsor: CIPLA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LENALIDOMIDE	LENALIDOMIDE	CAPSULE;ORAL	5MG	No	No
002	LENALIDOMIDE	LENALIDOMIDE	CAPSULE;ORAL	10MG	No	No
003	LENALIDOMIDE	LENALIDOMIDE	CAPSULE;ORAL	15MG	No	No
004	LENALIDOMIDE	LENALIDOMIDE	CAPSULE;ORAL	25MG	No	No
005	LENALIDOMIDE	LENALIDOMIDE	CAPSULE;ORAL	20MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69097-381	lenalidomide	lenalidomide	Cipla USA Inc.	ANDA	Current
69097-382	lenalidomide	lenalidomide	Cipla USA Inc.	ANDA	Current
69097-383	lenalidomide	lenalidomide	Cipla USA Inc.	ANDA	Current
69097-385	lenalidomide	lenalidomide	Cipla USA Inc.	ANDA	Current
76282-697	lenalidomide	lenalidomide	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-697	lenalidomide	lenalidomide	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-698	lenalidomide	lenalidomide	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-698	lenalidomide	lenalidomide	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-699	lenalidomide	lenalidomide	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-699	lenalidomide	lenalidomide	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-701	lenalidomide	lenalidomide	Exelan Pharmaceuticals, Inc.	ANDA	Current
76282-701	lenalidomide	lenalidomide	Exelan Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76344	ORIG	2023-11-06