Application 022291

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROMACTA	ELTROMBOPAG OLAMINE	TABLET;ORAL	EQ 25MG ACID	Yes	No
002	PROMACTA	ELTROMBOPAG OLAMINE	TABLET;ORAL	EQ 50MG ACID	Yes	No
003	PROMACTA	ELTROMBOPAG OLAMINE	TABLET;ORAL	EQ 75MG ACID	Yes	Yes
004	PROMACTA	ELTROMBOPAG OLAMINE	TABLET;ORAL	EQ 12.5MG ACID	Yes	No
005	PROMACTA	ELTROMBOPAG OLAMINE	TABLET;ORAL	EQ 100MG ACID	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0007-4640	PROMACTA	eltrombopag olamine	GlaxoSmithKline LLC	NDA	Current
0007-4641	PROMACTA	eltrombopag olamine	GlaxoSmithKline LLC	NDA	Current
0007-4642	PROMACTA	eltrombopag olamine	GlaxoSmithKline LLC	NDA	Current
0007-4643	PROMACTA	eltrombopag olamine	GlaxoSmithKline LLC	NDA	Current
0078-0684	PROMACTA	eltrombopag olamine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0684	PROMACTA	eltrombopag olamine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0684	PROMACTA	eltrombopag olamine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0684	PROMACTA	eltrombopag olamine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0684	PROMACTA	eltrombopag olamine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0684	PROMACTA	eltrombopag olamine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0684	PROMACTA	eltrombopag olamine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0684	PROMACTA	eltrombopag olamine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0684	PROMACTA	eltrombopag olamine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0684	PROMACTA	eltrombopag olamine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0685	PROMACTA	eltrombopag olamine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0685	PROMACTA	eltrombopag olamine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0685	PROMACTA	eltrombopag olamine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0685	PROMACTA	eltrombopag olamine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0685	PROMACTA	eltrombopag olamine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0685	PROMACTA	eltrombopag olamine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0685	PROMACTA	eltrombopag olamine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0685	PROMACTA	eltrombopag olamine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0685	PROMACTA	eltrombopag olamine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0685	PROMACTA	eltrombopag olamine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0686	PROMACTA	eltrombopag olamine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0686	PROMACTA	eltrombopag olamine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0686	PROMACTA	eltrombopag olamine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0686	PROMACTA	eltrombopag olamine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0686	PROMACTA	eltrombopag olamine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0686	PROMACTA	eltrombopag olamine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0686	PROMACTA	eltrombopag olamine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0686	PROMACTA	eltrombopag olamine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0686	PROMACTA	eltrombopag olamine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0686	PROMACTA	eltrombopag olamine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0687	PROMACTA	eltrombopag olamine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0687	PROMACTA	eltrombopag olamine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0687	PROMACTA	eltrombopag olamine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0687	PROMACTA	eltrombopag olamine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0687	PROMACTA	eltrombopag olamine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0687	PROMACTA	eltrombopag olamine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0687	PROMACTA	eltrombopag olamine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0687	PROMACTA	eltrombopag olamine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0687	PROMACTA	eltrombopag olamine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0687	PROMACTA	eltrombopag olamine	Novartis Pharmaceuticals Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84208	SUPPL	2025-11-19
84207	SUPPL	2025-11-19
83225	SUPPL	2025-08-29
83224	SUPPL	2025-08-29
82505	SUPPL	2025-06-09
82497	SUPPL	2025-06-09
82494	SUPPL	2025-06-09
75515	SUPPL	2023-09-20
75512	SUPPL	2023-09-19
73735	SUPPL	2023-03-10
73719	SUPPL	2023-03-10
73252	SUPPL	2023-01-19
73181	SUPPL	2023-01-17
73180	SUPPL	2023-01-17
70691	SUPPL	2022-04-05
70690	SUPPL	2022-04-05
70682	SUPPL	2022-04-04
67214	SUPPL	2021-04-28
67212	SUPPL	2021-04-28
66092	SUPPL	2021-02-04
66091	SUPPL	2021-02-04
62796	SUPPL	2020-05-01
62795	SUPPL	2020-05-01
62767	SUPPL	2020-04-30
62734	SUPPL	2020-04-29
56691	SUPPL	2018-12-07
56502	SUPPL	2018-11-19
56501	SUPPL	2018-11-19
54999	SUPPL	2018-07-26
54966	SUPPL	2018-07-25
49971	SUPPL	2017-10-06
49953	SUPPL	2017-10-05
48932	SUPPL	2017-07-10
47550	SUPPL	2017-03-14
47518	SUPPL	2017-03-10
45615	SUPPL	2016-10-17
29543	SUPPL	2015-06-12
17209	SUPPL	2015-06-12
38523	SUPPL	2015-04-10
7193	SUPPL	2015-04-08
7191	SUPPL	2014-08-28
38522	SUPPL	2014-08-27
7192	SUPPL	2014-07-17
29542	SUPPL	2014-04-28
17208	SUPPL	2014-04-28
7190	SUPPL	2014-02-12
17207	SUPPL	2014-02-11
38521	SUPPL	2012-11-19
7189	SUPPL	2012-11-19
7188	SUPPL	2011-12-07
17206	SUPPL	2011-12-06
51701	SUPPL	2011-11-23
38520	SUPPL	2011-03-04
7187	SUPPL	2011-03-02
29541	SUPPL	2010-03-09
51699	SUPPL	2010-01-25
44727	ORIG	2009-01-14
21984	ORIG	2009-01-14
7186	ORIG	2008-11-26
38519	ORIG	2008-11-21
64671	ORIG	1900-01-01
63905	ORIG	1900-01-01
52450	SUPPL	1900-01-01
52449	SUPPL	1900-01-01
52448	SUPPL	1900-01-01

Application 022291

Related Records#

Application Products#

NDC Listings For This Application#

Documents#