Application 021880

Type: NDA
Sponsor: CELGENE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	REVLIMID	LENALIDOMIDE	CAPSULE;ORAL	5MG	Yes	No
002	REVLIMID	LENALIDOMIDE	CAPSULE;ORAL	10MG	Yes	No
003	REVLIMID	LENALIDOMIDE	CAPSULE;ORAL	15MG	Yes	No
004	REVLIMID	LENALIDOMIDE	CAPSULE;ORAL	25MG	Yes	Yes
005	REVLIMID	LENALIDOMIDE	CAPSULE;ORAL	2.5MG	Yes	No
006	REVLIMID	LENALIDOMIDE	CAPSULE;ORAL	20MG	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59572-402	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-402	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-402	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-402	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-402	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-402	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-402	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-402	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-402	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-405	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-405	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-405	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-405	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-405	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-405	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-405	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-405	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-405	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-410	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-410	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-410	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-410	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-410	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-410	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-410	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-410	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-410	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-415	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-415	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-415	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-415	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-415	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-415	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-415	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-415	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-415	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-420	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-420	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-420	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-420	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-420	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-420	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-420	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-420	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-420	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-425	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-425	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-425	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-425	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-425	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-425	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-425	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-425	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current
59572-425	Revlimid	Lenalidomide	Celgene Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85783	SUPPL	2026-05-01
76518	ORIG	2023-11-07
73879	SUPPL	2023-03-27
73878	SUPPL	2023-03-27
73868	SUPPL	2023-03-27
71144	SUPPL	2022-05-25
71143	SUPPL	2022-05-25
71142	SUPPL	2022-05-25
68545	SUPPL	2021-09-07
68544	SUPPL	2021-09-07
68509	SUPPL	2021-09-01
68320	SUPPL	2021-08-09
64676	SUPPL	2020-09-25
60758	SUPPL	2019-10-31
60757	SUPPL	2019-10-31
60750	SUPPL	2019-10-31
58964	SUPPL	2019-06-04
58865	SUPPL	2019-05-28
58864	SUPPL	2019-05-28
57522	SUPPL	2019-02-13
57329	SUPPL	2019-01-23
57328	SUPPL	2019-01-23
50954	SUPPL	2018-01-02
50953	SUPPL	2018-01-02
50947	SUPPL	2017-12-29
50573	SUPPL	2017-12-01
50572	SUPPL	2017-12-01
50544	SUPPL	2017-11-30
50543	SUPPL	2017-11-30
49787	SUPPL	2017-09-19
49773	SUPPL	2017-09-18
48868	SUPPL	2017-06-29
47298	SUPPL	2017-02-23
47289	SUPPL	2017-02-22
6373	SUPPL	2016-04-26
28771	SUPPL	2015-12-02
6372	SUPPL	2015-10-29
6371	SUPPL	2015-09-15
16515	SUPPL	2015-02-24
28770	SUPPL	2015-02-19
37814	SUPPL	2014-09-19
16514	SUPPL	2014-09-19
28769	SUPPL	2014-09-16
6370	SUPPL	2014-09-16
6368	SUPPL	2013-11-18
6369	SUPPL	2013-11-07
37813	SUPPL	2013-11-04
28768	SUPPL	2013-06-06
37812	SUPPL	2013-06-05
37811	SUPPL	2013-02-12
28767	SUPPL	2013-02-12
16513	SUPPL	2013-02-12
6367	SUPPL	2013-02-12
28766	SUPPL	2012-05-11
37810	SUPPL	2012-05-10
6366	SUPPL	2012-03-14
37809	SUPPL	2012-03-12
6365	SUPPL	2011-12-28
16512	SUPPL	2011-12-23
28765	SUPPL	2010-10-19
16511	SUPPL	2010-10-19
24011	ORIG	2010-08-16
16509	SUPPL	2010-08-10
6363	SUPPL	2010-08-09
28764	SUPPL	2009-03-03
28763	SUPPL	2009-03-03
6364	SUPPL	2009-03-03
37808	SUPPL	2009-02-24
37807	SUPPL	2009-02-24
16510	SUPPL	2009-02-24
28762	SUPPL	2006-07-13
37806	SUPPL	2006-07-03
21855	ORIG	2006-02-08
28761	ORIG	2006-01-06
37805	ORIG	2005-12-28
23682	ORIG	2005-12-28

Application 021880

Related Records#

Application Products#

NDC Listings For This Application#

Documents#