Application 204026

Type: NDA
Sponsor: CELGENE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	POMALYST	POMALIDOMIDE	CAPSULE;ORAL	1MG	Yes	No
002	POMALYST	POMALIDOMIDE	CAPSULE;ORAL	2MG	Yes	No
003	POMALYST	POMALIDOMIDE	CAPSULE;ORAL	3MG	Yes	No
004	POMALYST	POMALIDOMIDE	CAPSULE;ORAL	4MG	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59572-501	Pomalyst	pomalidomide	Celgene Corporation	NDA	Current
59572-501	Pomalyst	pomalidomide	Celgene Corporation	NDA	Current
59572-501	Pomalyst	pomalidomide	Celgene Corporation	NDA	Current
59572-501	Pomalyst	pomalidomide	Celgene Corporation	NDA	Current
59572-501	Pomalyst	pomalidomide	Celgene Corporation	NDA	Current
59572-501	Pomalyst	pomalidomide	Celgene Corporation	NDA	Current
59572-501	Pomalyst	pomalidomide	Celgene Corporation	NDA	Current
59572-502	Pomalyst	pomalidomide	Celgene Corporation	NDA	Current
59572-502	Pomalyst	pomalidomide	Celgene Corporation	NDA	Current
59572-502	Pomalyst	pomalidomide	Celgene Corporation	NDA	Current
59572-502	Pomalyst	pomalidomide	Celgene Corporation	NDA	Current
59572-502	Pomalyst	pomalidomide	Celgene Corporation	NDA	Current
59572-502	Pomalyst	pomalidomide	Celgene Corporation	NDA	Current
59572-502	Pomalyst	pomalidomide	Celgene Corporation	NDA	Current
59572-503	Pomalyst	pomalidomide	Celgene Corporation	NDA	Current
59572-503	Pomalyst	pomalidomide	Celgene Corporation	NDA	Current
59572-503	Pomalyst	pomalidomide	Celgene Corporation	NDA	Current
59572-503	Pomalyst	pomalidomide	Celgene Corporation	NDA	Current
59572-503	Pomalyst	pomalidomide	Celgene Corporation	NDA	Current
59572-503	Pomalyst	pomalidomide	Celgene Corporation	NDA	Current
59572-503	Pomalyst	pomalidomide	Celgene Corporation	NDA	Current
59572-504	Pomalyst	pomalidomide	Celgene Corporation	NDA	Current
59572-504	Pomalyst	pomalidomide	Celgene Corporation	NDA	Current
59572-504	Pomalyst	pomalidomide	Celgene Corporation	NDA	Current
59572-504	Pomalyst	pomalidomide	Celgene Corporation	NDA	Current
59572-504	Pomalyst	pomalidomide	Celgene Corporation	NDA	Current
59572-504	Pomalyst	pomalidomide	Celgene Corporation	NDA	Current
59572-504	Pomalyst	pomalidomide	Celgene Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85784	SUPPL	2026-05-01
81380	SUPPL	2025-02-27
81379	SUPPL	2025-02-27
81376	SUPPL	2025-02-27
73882	SUPPL	2023-03-27
73869	SUPPL	2023-03-27
68322	SUPPL	2021-08-09
65510	SUPPL	2020-12-07
65495	SUPPL	2020-12-03
65315	SUPPL	2020-11-25
65314	SUPPL	2020-11-25
65311	SUPPL	2020-11-25
63037	SUPPL	2020-05-15
63036	SUPPL	2020-05-15
63017	SUPPL	2020-05-15
63016	SUPPL	2020-05-15
63014	SUPPL	2020-05-15
63013	SUPPL	2020-05-15
60760	SUPPL	2019-10-31
60759	SUPPL	2019-10-31
60751	SUPPL	2019-10-31
53495	SUPPL	2018-03-28
53257	SUPPL	2018-03-23
53256	SUPPL	2018-03-23
50955	SUPPL	2018-01-02
50948	SUPPL	2017-12-29
50569	SUPPL	2017-12-01
50541	SUPPL	2017-12-01
48866	SUPPL	2017-06-29
40343	SUPPL	2016-07-05
40342	SUPPL	2016-07-05
10283	SUPPL	2016-07-01
10281	SUPPL	2016-07-01
10282	SUPPL	2016-04-25
10280	SUPPL	2015-12-02
10279	SUPPL	2015-10-28
10278	SUPPL	2015-09-16
40341	SUPPL	2015-04-28
40340	SUPPL	2015-04-28
19514	SUPPL	2015-04-28
10277	SUPPL	2015-04-24
10276	SUPPL	2015-04-24
10275	SUPPL	2015-04-24
32491	SUPPL	2014-09-16
19513	SUPPL	2014-03-19
10274	SUPPL	2014-03-19
10273	SUPPL	2013-11-18
43452	ORIG	2013-03-20
24455	ORIG	2013-03-20
24119	ORIG	2013-02-12
10272	ORIG	2013-02-11
19512	ORIG	2013-02-08

Application 204026

Related Records#

Application Products#

NDC Listings For This Application#

Documents#