Application 021266

Type: NDA
Sponsor: PF PRISM CV

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VFEND	VORICONAZOLE	TABLET;ORAL	50MG	Yes	No
002	VFEND	VORICONAZOLE	TABLET;ORAL	200MG	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0049-3170	VFEND	voriconazole	Roerig	NDA	Current
0049-3170	VFEND	voriconazole	Roerig	NDA	Current
0049-3170	VFEND	voriconazole	Roerig	NDA	Current
0049-3170	VFEND	voriconazole	Roerig	NDA	Current
0049-3170	VFEND	voriconazole	Roerig	NDA	Current
0049-3170	VFEND	voriconazole	Roerig	NDA	Current
0049-3170	VFEND	voriconazole	Roerig	NDA	Current
0049-3170	VFEND	voriconazole	Roerig	NDA	Current
0049-3170	VFEND	voriconazole	Roerig	NDA	Current
0049-3170	VFEND	voriconazole	Roerig	NDA	Current
0049-3170	VFEND	voriconazole	Roerig	NDA	Current
0049-3170	VFEND	voriconazole	Roerig	NDA	Current
0049-3180	VFEND	voriconazole	Roerig	NDA	Current
0049-3180	VFEND	voriconazole	Roerig	NDA	Current
0049-3180	VFEND	voriconazole	Roerig	NDA	Current
0049-3180	VFEND	voriconazole	Roerig	NDA	Current
0049-3180	VFEND	voriconazole	Roerig	NDA	Current
0049-3180	VFEND	voriconazole	Roerig	NDA	Current
0049-3180	VFEND	voriconazole	Roerig	NDA	Current
0049-3180	VFEND	voriconazole	Roerig	NDA	Current
0049-3180	VFEND	voriconazole	Roerig	NDA	Current
0049-3180	VFEND	voriconazole	Roerig	NDA	Current
0049-3180	VFEND	voriconazole	Roerig	NDA	Current
0049-3180	VFEND	voriconazole	Roerig	NDA	Current
55154-2725	VFEND	voriconazole	Cardinal Health	NDA	Current
59762-0930	Voriconazole	Voriconazole	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0930	Voriconazole	Voriconazole	Greenstone LLC	NDA	Current
59762-0930	Voriconazole	Voriconazole	Greenstone LLC	NDA	Current
59762-0930	Voriconazole	Voriconazole	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0930	Voriconazole	Voriconazole	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0930	Voriconazole	Voriconazole	Greenstone LLC	NDA	Current
59762-0934	Voriconazole	Voriconazole	Greenstone LLC	NDA	Current
59762-0934	Voriconazole	Voriconazole	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0934	Voriconazole	Voriconazole	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0934	Voriconazole	Voriconazole	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0934	Voriconazole	Voriconazole	Greenstone LLC	NDA	Current
59762-0934	Voriconazole	Voriconazole	Greenstone LLC	NDA	Current
59762-0934	Voriconazole	Voriconazole	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0934	Voriconazole	Voriconazole	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0934	Voriconazole	Voriconazole	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0934	Voriconazole	Voriconazole	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0934	Voriconazole	Voriconazole	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0934	Voriconazole	Voriconazole	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0936	Voriconazole	Voriconazole	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0936	Voriconazole	Voriconazole	Greenstone LLC	NDA	Current
59762-0936	Voriconazole	Voriconazole	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0936	Voriconazole	Voriconazole	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0936	Voriconazole	Voriconazole	Greenstone LLC	NDA	Current
59762-0936	Voriconazole	Voriconazole	Greenstone LLC	NDA	Current
59762-0936	Voriconazole	Voriconazole	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0936	Voriconazole	Voriconazole	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0936	Voriconazole	Voriconazole	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0936	Voriconazole	Voriconazole	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0936	Voriconazole	Voriconazole	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-0936	Voriconazole	Voriconazole	Greenstone LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85125	SUPPL	2026-02-24
85104	SUPPL	2026-02-23
84875	SUPPL	2026-01-29
84869	SUPPL	2026-01-29
81575	SUPPL	2025-03-17
81558	SUPPL	2025-03-14
72431	SUPPL	2022-10-21
72408	SUPPL	2022-10-19
71830	SUPPL	2022-08-17
71818	SUPPL	2022-08-17
70030	SUPPL	2022-02-01
70012	SUPPL	2022-01-31
68995	SUPPL	2021-10-14
68983	SUPPL	2021-10-14
67094	SUPPL	2021-04-19
67091	SUPPL	2021-04-19
65993	SUPPL	2021-01-26
65982	SUPPL	2021-01-26
65978	SUPPL	2021-01-26
65927	SUPPL	2021-01-19
64526	SUPPL	2020-09-08
64521	SUPPL	2020-09-08
58517	SUPPL	2019-05-02
58497	SUPPL	2019-05-01
57557	SUPPL	2019-02-13
57380	SUPPL	2019-01-30
49187	SUPPL	2017-08-02
49157	SUPPL	2017-07-31
48762	SUPPL	2017-06-19
48742	SUPPL	2017-06-16
14798	SUPPL	2015-02-05
4839	SUPPL	2015-02-05
27277	SUPPL	2014-04-08
14797	SUPPL	2014-04-08
21558	SUPPL	2012-11-09
36514	SUPPL	2011-11-21
27276	SUPPL	2011-11-21
36513	SUPPL	2011-06-16
4838	SUPPL	2011-06-02
14796	SUPPL	2010-12-26
4836	SUPPL	2010-12-21
4837	SUPPL	2010-11-30
36512	SUPPL	2010-11-21
36511	SUPPL	2010-06-24
36510	SUPPL	2010-06-24
27275	SUPPL	2010-06-24
27274	SUPPL	2010-06-24
27273	SUPPL	2010-06-24
14795	SUPPL	2010-06-24
14794	SUPPL	2010-06-24
4835	SUPPL	2010-06-24
27265	ORIG	2010-04-28
21556	ORIG	2010-04-28
14784	ORIG	2010-04-28
27272	SUPPL	2008-06-03
36509	SUPPL	2008-03-13
4834	SUPPL	2008-03-13
14792	SUPPL	2008-02-14
27271	SUPPL	2008-02-07
42063	SUPPL	2007-01-10
21557	SUPPL	2007-01-10
4833	SUPPL	2006-12-28
14793	SUPPL	2006-12-04
36508	SUPPL	2006-05-22
4832	SUPPL	2006-05-22
27270	SUPPL	2006-03-22
14791	SUPPL	2006-03-22
4831	SUPPL	2006-01-19
14790	SUPPL	2006-01-05
4830	SUPPL	2005-07-15
14789	SUPPL	2005-07-08
14788	SUPPL	2005-03-29
4829	SUPPL	2005-03-29
36507	SUPPL	2004-12-29
27269	SUPPL	2004-12-29
14786	SUPPL	2004-05-04
14785	SUPPL	2004-05-04
27267	SUPPL	2004-04-29
4828	SUPPL	2004-04-29
14787	SUPPL	2004-03-03
27268	SUPPL	2004-02-27
27266	SUPPL	2003-04-14
36506	SUPPL	2003-03-28

Application 021266

Related Records#

Application Products#

NDC Listings For This Application#

Documents#