Application 021938

Type: NDA
Sponsor: CPPI CV

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SUTENT	SUNITINIB MALATE	CAPSULE;ORAL	EQ 12.5MG BASE	Yes	No
002	SUTENT	SUNITINIB MALATE	CAPSULE;ORAL	EQ 25MG BASE	Yes	No
003	SUTENT	SUNITINIB MALATE	CAPSULE;ORAL	EQ 50MG BASE	Yes	Yes
004	SUTENT	SUNITINIB MALATE	CAPSULE;ORAL	EQ 37.5MG BASE	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0069-0550	SUTENT	Sunitinib malate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0550	SUTENT	Sunitinib malate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0550	SUTENT	Sunitinib malate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0550	SUTENT	Sunitinib malate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0550	SUTENT	Sunitinib malate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0550	SUTENT	Sunitinib malate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0550	SUTENT	Sunitinib malate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0550	SUTENT	Sunitinib malate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0550	SUTENT	Sunitinib malate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0770	SUTENT	Sunitinib malate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0770	SUTENT	Sunitinib malate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0770	SUTENT	Sunitinib malate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0770	SUTENT	Sunitinib malate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0770	SUTENT	Sunitinib malate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0770	SUTENT	Sunitinib malate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0770	SUTENT	Sunitinib malate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0770	SUTENT	Sunitinib malate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0770	SUTENT	Sunitinib malate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0830	SUTENT	Sunitinib malate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0830	SUTENT	Sunitinib malate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0830	SUTENT	Sunitinib malate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0830	SUTENT	Sunitinib malate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0830	SUTENT	Sunitinib malate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0830	SUTENT	Sunitinib malate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0830	SUTENT	Sunitinib malate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0830	SUTENT	Sunitinib malate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0830	SUTENT	Sunitinib malate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0980	SUTENT	Sunitinib malate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0980	SUTENT	Sunitinib malate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0980	SUTENT	Sunitinib malate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0980	SUTENT	Sunitinib malate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0980	SUTENT	Sunitinib malate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0980	SUTENT	Sunitinib malate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0980	SUTENT	Sunitinib malate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0980	SUTENT	Sunitinib malate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
0069-0980	SUTENT	Sunitinib malate	Pfizer Laboratories Div Pfizer Inc	NDA	Current
63539-017	SUTENT	Sunitinib malate	U.S. Pharmaceuticals	NDA	Current
63539-017	SUTENT	Sunitinib malate	U.S. Pharmaceuticals	NDA	Current
63539-017	SUTENT	Sunitinib malate	U.S. Pharmaceuticals	NDA	Current
63539-019	SUTENT	Sunitinib malate	U.S. Pharmaceuticals	NDA	Current
63539-019	SUTENT	Sunitinib malate	U.S. Pharmaceuticals	NDA	Current
63539-019	SUTENT	Sunitinib malate	U.S. Pharmaceuticals	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
68514	SUPPL	2021-09-02
68513	SUPPL	2021-09-02
68495	SUPPL	2021-08-31
64289	SUPPL	2020-08-17
64286	SUPPL	2020-08-17
64285	SUPPL	2020-08-17
63874	SUPPL	2020-07-13
63873	SUPPL	2020-07-13
63855	SUPPL	2020-07-13
58640	SUPPL	2019-05-13
58614	SUPPL	2019-05-08
58613	SUPPL	2019-05-08
57150	SUPPL	2019-01-09
56881	SUPPL	2018-12-20
50448	SUPPL	2017-11-17
50435	SUPPL	2017-11-16
37932	SUPPL	2015-11-19
28899	SUPPL	2015-11-17
37931	SUPPL	2015-04-28
16617	SUPPL	2015-04-28
28898	SUPPL	2015-04-27
6511	SUPPL	2015-04-27
37930	SUPPL	2014-12-23
6510	SUPPL	2014-12-23
6509	SUPPL	2014-06-12
37929	SUPPL	2013-09-09
16616	SUPPL	2013-09-09
28897	SUPPL	2013-09-04
28896	SUPPL	2013-09-04
37928	SUPPL	2012-11-19
37927	SUPPL	2012-11-19
28895	SUPPL	2012-11-19
16615	SUPPL	2012-11-19
6508	SUPPL	2012-11-19
6507	SUPPL	2012-11-19
37926	SUPPL	2012-04-24
28894	SUPPL	2012-04-24
16614	SUPPL	2012-04-24
6506	SUPPL	2012-04-24
28892	SUPPL	2011-05-25
6505	SUPPL	2011-05-25
6504	SUPPL	2011-05-25
43555	SUPPL	2011-05-20
37925	SUPPL	2011-05-20
37923	SUPPL	2011-05-20
16613	SUPPL	2011-05-20
37921	SUPPL	2010-09-22
37920	SUPPL	2010-09-22
28889	SUPPL	2010-09-22
16609	SUPPL	2010-09-22
6501	SUPPL	2010-09-22
6500	SUPPL	2010-09-22
43802	ORIG	2010-07-16
37924	SUPPL	2010-07-06
37922	SUPPL	2010-07-06
28893	SUPPL	2010-07-06
28891	SUPPL	2010-07-06
16612	SUPPL	2010-07-06
16611	SUPPL	2010-07-06
6503	SUPPL	2010-07-06
6502	SUPPL	2010-07-06
28890	SUPPL	2009-04-03
16610	SUPPL	2009-04-03
28888	SUPPL	2007-02-12
28887	SUPPL	2007-02-12
28886	SUPPL	2007-02-12
6499	SUPPL	2007-02-12
37919	SUPPL	2007-02-05
16608	SUPPL	2007-02-05
16607	SUPPL	2007-02-05
37918	SUPPL	2007-02-02
21880	SUPPL	2007-02-02
21879	SUPPL	2007-02-02
21878	SUPPL	2007-02-02
21877	SUPPL	2007-02-02
21876	ORIG	2006-04-06
28885	ORIG	2006-01-30
37917	ORIG	2006-01-26
66908	ORIG	1900-01-01
66907	ORIG	1900-01-01
63244	SUPPL	1900-01-01

Application 021938

Related Records#

Application Products#

NDC Listings For This Application#

Documents#