Application 020825

Type: NDA
Sponsor: PFIZER

Related Records

Company: PFIZER

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GEODON	ZIPRASIDONE HYDROCHLORIDE	CAPSULE;ORAL	EQ 20MG BASE	Yes	Yes
002	GEODON	ZIPRASIDONE HYDROCHLORIDE	CAPSULE;ORAL	EQ 40MG BASE	Yes	No
003	GEODON	ZIPRASIDONE HYDROCHLORIDE	CAPSULE;ORAL	EQ 60MG BASE	Yes	No
004	GEODON	ZIPRASIDONE HYDROCHLORIDE	CAPSULE;ORAL	EQ 80MG BASE	Yes	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0049-0052	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-0052	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-0052	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-0052	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-0052	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-0052	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-0052	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-0052	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-0052	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-0052	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-0054	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-0054	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-0054	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-0054	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-0054	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-0054	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-0054	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-0054	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-0054	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-0054	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-0056	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-0056	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-0056	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-0056	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-0056	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-0056	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-0056	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-0056	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-0056	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-0056	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-0058	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-0058	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-0058	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-0058	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-0058	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-0058	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-0058	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-0058	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-0058	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-0058	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-0352	Geodon	ziprasidone	Roerig	NDA	Current
0049-0352	Geodon	ziprasidone	Roerig	NDA	Current
0049-0352	Geodon	ziprasidone	Roerig	NDA	Current
0049-0352	Geodon	ziprasidone	Roerig	NDA	Current
0049-0356	Geodon	ziprasidone	Roerig	NDA	Current
0049-0356	Geodon	ziprasidone	Roerig	NDA	Current
0049-0356	Geodon	ziprasidone	Roerig	NDA	Current
0049-0356	Geodon	ziprasidone	Roerig	NDA	Current
0049-0358	Geodon	ziprasidone	Roerig	NDA	Current
0049-0358	Geodon	ziprasidone	Roerig	NDA	Current
0049-0358	Geodon	ziprasidone	Roerig	NDA	Current
0049-0358	Geodon	ziprasidone	Roerig	NDA	Current
0049-3960	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-3960	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-3960	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-3960	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-3960	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-3970	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-3980	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-3980	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-3980	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-3980	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-3980	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-3990	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-3990	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-3990	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-3990	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
0049-3990	Geodon	ziprasidone hydrochloride	Roerig	NDA	Current
21695-060	Geodon	ziprasidone hydrochloride	Rebel Distributors Corp	NDA	Current
21695-061	Geodon	ziprasidone hydrochloride	Rebel Distributors Corp	NDA	Current
21695-062	Geodon	ziprasidone hydrochloride	Rebel Distributors Corp	NDA	Current
21695-063	Geodon	ziprasidone hydrochloride	Rebel Distributors Corp	NDA	Current
53808-0252	Geodon	ziprasidone hydrochloride	State of Florida DOH Central Pharmacy	NDA	Current
53808-0253	Geodon	ziprasidone hydrochloride	State of Florida DOH Central Pharmacy	NDA	Current
53808-0254	Geodon	ziprasidone hydrochloride	State of Florida DOH Central Pharmacy	NDA	Current
53808-0255	Geodon	ziprasidone hydrochloride	State of Florida DOH Central Pharmacy	NDA	Current
59762-1006	Ziprasidone	ziprasidone	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-1006	Ziprasidone	ziprasidone	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-2001	Ziprasidone	ziprasidone hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current
59762-2001	Ziprasidone	ziprasidone hydrochloride	Greenstone LLC	NDA AUTHORIZED GENERIC	Current

Documents

Document	Submission type	Date
81062	SUPPL	2025-02-06
80945	SUPPL	2025-02-05
70033	SUPPL	2022-02-01
70009	SUPPL	2022-01-31
67560	SUPPL	2021-05-20
67551	SUPPL	2021-05-19
66066	SUPPL	2021-02-02
65115	SUPPL	2020-11-02
61642	SUPPL	2020-01-24
61633	SUPPL	2020-01-24
56499	SUPPL	2018-11-16
56314	SUPPL	2018-11-06
47417	SUPPL	2017-03-02
47314	SUPPL	2017-02-24
35429	SUPPL	2015-09-14
25933	SUPPL	2015-08-24
35428	SUPPL	2014-12-11
3439	SUPPL	2014-12-11
35427	SUPPL	2013-12-19
25932	SUPPL	2013-12-19
3438	SUPPL	2013-08-16
13501	SUPPL	2013-08-15
35425	SUPPL	2013-07-05
3437	SUPPL	2013-07-05
25931	SUPPL	2013-03-05
35426	SUPPL	2013-03-04
20984	SUPPL	2012-10-12
44074	ORIG	2011-12-22
25930	SUPPL	2010-12-07
13500	SUPPL	2010-12-04
25928	SUPPL	2009-11-24
13499	SUPPL	2009-11-23
35424	SUPPL	2009-08-14
25929	SUPPL	2009-08-04
3436	SUPPL	2008-08-19
20983	SUPPL	2008-07-30
3435	SUPPL	2008-05-21
25927	SUPPL	2007-10-04
13498	SUPPL	2007-10-04
35423	SUPPL	2007-05-29
3434	SUPPL	2007-05-29
13497	SUPPL	2007-03-07
3433	SUPPL	2007-03-07
35422	SUPPL	2005-08-19
35421	SUPPL	2005-08-19
25926	SUPPL	2005-08-19
3432	SUPPL	2005-08-19
44466	SUPPL	2004-10-01
25925	SUPPL	2004-10-01
13496	SUPPL	2004-10-01
3431	SUPPL	2004-08-25
25924	SUPPL	2003-12-24
25923	SUPPL	2002-02-15
41723	ORIG	2001-02-05
25922	ORIG	2001-02-05
13495	ORIG	2001-02-05
53446	ORIG	1900-01-01
53445	ORIG	1900-01-01
53441	ORIG	1900-01-01
53440	ORIG	1900-01-01