Application 020919

Type: NDA
Sponsor: PFIZER

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GEODON	ZIPRASIDONE MESYLATE	INJECTABLE;INTRAMUSCULAR	EQ 20MG BASE/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020919-001	GEODON	ZIPRASIDONE MESYLATE	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	RLD, RS	2002-06-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N020919-001	AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020919-001	GEODON	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	RLD, RS	2002-06-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020919-001	GEODON	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	RLD, RS	2002-06-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020919-001	GEODON	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	RLD, RS	2002-06-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020919-001	GEODON	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	RLD, RS	2002-06-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020919-001	GEODON	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	RLD, RS	2002-06-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020919-001	GEODON	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	RLD, RS	2002-06-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020919-001	GEODON	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	RLD, RS	2002-06-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020919-001	GEODON	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	RLD, RS	2002-06-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020919-001	GEODON	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	RLD, RS	2002-06-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020919-001	GEODON	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	RLD, RS	2002-06-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020919-001	GEODON	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	RLD, RS	2002-06-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020919-001	GEODON	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	RLD, RS	2002-06-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020919-001	GEODON	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	RLD, RS	2002-06-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020919-001	GEODON	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	RLD, RS	2002-06-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020919-001	GEODON	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	RLD, RS	2002-06-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020919-001	GEODON	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	RLD, RS	2002-06-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020919-001	GEODON	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	RLD, RS	2002-06-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020919-001	GEODON	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	RLD, RS	2002-06-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020919-001	GEODON	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	RLD, RS	2002-06-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020919-001	GEODON	EQ 20MG BASE/ML	INJECTABLE / INTRAMUSCULAR		RLD, RS	2002-06-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020919-001	GEODON	EQ 20MG BASE/ML	INJECTABLE / INTRAMUSCULAR	AP	RLD, RS	2002-06-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020919-001	GEODON	EQ 20MG BASE/ML	INJECTABLE / INTRAMUSCULAR	AP	RLD, RS	2002-06-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020919-001	GEODON	EQ 20MG BASE/ML	INJECTABLE / INTRAMUSCULAR	AP	RLD, RS	2002-06-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020919-001	GEODON	EQ 20MG BASE/ML	INJECTABLE / INTRAMUSCULAR	AP	RLD, RS	2002-06-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020919-001	GEODON	EQ 20MG BASE/ML	INJECTABLE / INTRAMUSCULAR	AP	RLD, RS	2002-06-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020919-001	GEODON	EQ 20MG BASE/ML	INJECTABLE / INTRAMUSCULAR	AP	RLD, RS	2002-06-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020919-001	GEODON	EQ 20MG BASE/ML	INJECTABLE / INTRAMUSCULAR		RLD, RS	2002-06-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020919-001	GEODON	EQ 20MG BASE/ML	INJECTABLE / INTRAMUSCULAR		RLD, RS	2002-06-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020919-001	GEODON	EQ 20MG BASE/ML	INJECTABLE / INTRAMUSCULAR		RLD, RS	2002-06-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020919-001	GEODON	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	RLD, RS	2002-06-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020919-001	GEODON	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	RLD, RS	2002-06-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020919-001	GEODON	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	RLD, RS	2002-06-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020919-001	GEODON	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	RLD, RS	2002-06-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020919-001	GEODON	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	RLD, RS	2002-06-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020919-001	GEODON	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	RLD, RS	2002-06-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020919-001	GEODON	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	RLD, RS	2002-06-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020919-001	GEODON	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	RLD, RS	2002-06-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020919-001	GEODON	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	RLD, RS	2002-06-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020919-001	GEODON	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	RLD, RS	2002-06-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020919-001	GEODON	EQ 20MG BASE/VIAL	POWDER / INTRAMUSCULAR	AP	RLD, RS	2002-06-21	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N020919-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020919-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020919-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020919-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020919-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020919-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020919-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020919-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020919-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020919-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020919-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020919-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020919-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020919-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020919-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020919-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020919-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020919-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020919-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N020919-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020919-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020919-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020919-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020919-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020919-001	AP	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020919-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020919-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020919-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020919-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020919-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020919-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020919-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020919-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020919-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020919-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020919-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020919-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020919-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020919-001	AP	1	`a50c72e98297…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ziprasidone Mesylate	ZIPRASIDONE MESYLATE	STERISCIENCE SPECIALTIES PRIVATE LIMITED	1ffd16c3-25ac-4839-9ea9-4efd32926b95	2025-09-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIPRASIDONE MESYLATE
ziprasidone mesylate	ZIPRASIDONE MESYLATE	Novadoz Pharmaceuticals LLC	90b35a26-ab65-4c39-b97f-55c8c0e34b0b	2025-08-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIPRASIDONE MESYLATE
Ziprasidone Mesylate	ZIPRASIDONE MESYLATE	Fosun Pharma USA Inc.	b28a4f3d-0aae-050d-e053-2995a90aa4a6	2025-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIPRASIDONE MESYLATE
Ziprasidone Mesylate	ZIPRASIDONE MESYLATE	Fosun Pharma USA Inc.	90f55022-8d58-4bfb-9464-9bf11395ae17	2025-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIPRASIDONE MESYLATE
ziprasidone mesylate	ZIPRASIDONE MESYLATE	Gland Pharma Limited	77a10f48-e300-465f-81b5-54be38daa4b3	2025-03-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIPRASIDONE MESYLATE
ZIPRASIDONE MESYLATE	ZIPRASIDONE MESYLATE	HF Acquisition Co LLC, DBA HealthFirst	c75971f8-9640-a6e8-e053-2995a90af654	2024-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIPRASIDONE MESYLATE
ziprasidone mesylate	ZIPRASIDONE MESYLATE	Dr.Reddy's Laboratories, Inc.	3cb79985-1207-602e-2dda-a118133b4c60	2021-07-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIPRASIDONE MESYLATE
ziprasidone mesylate	ZIPRASIDONE MESYLATE	Dr.Reddy's Laboratories, Inc.	6fd6fc45-20c4-e223-3532-ce37aa02b71c	2021-07-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIPRASIDONE MESYLATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0049-1203	Geodon	ziprasidone mesylate	Roerig	NDA	Current
0049-1203	Geodon	ziprasidone mesylate	Roerig	NDA	Current
0049-1203	Geodon	ziprasidone mesylate	Roerig	NDA	Current
0049-1203	Geodon	ziprasidone mesylate	Roerig	NDA	Current
0049-3920	Geodon	ziprasidone mesylate	Roerig	NDA	Current
0049-3920	Geodon	ziprasidone mesylate	Roerig	NDA	Current
0049-3920	Geodon	ziprasidone mesylate	Roerig	NDA	Current
0049-3920	Geodon	ziprasidone mesylate	Roerig	NDA	Current
0049-3920	Geodon	ziprasidone mesylate	Roerig	NDA	Current
0049-3920	Geodon	ziprasidone mesylate	Roerig	NDA	Current
0049-3920	Geodon	ziprasidone mesylate	Roerig	NDA	Current
0049-3920	Geodon	ziprasidone mesylate	Roerig	NDA	Current
0049-3920	Geodon	ziprasidone mesylate	Roerig	NDA	Current
0049-3920	Geodon	ziprasidone mesylate	Roerig	NDA	Current
50090-4540	Geodon	ziprasidone mesylate	A-S Medication Solutions	NDA	Current
50090-4540	Geodon	ziprasidone mesylate	A-S Medication Solutions	NDA	Current
50090-4540	Geodon	ziprasidone mesylate	A-S Medication Solutions	NDA	Current
50090-4540	Geodon	ziprasidone mesylate	A-S Medication Solutions	NDA	Current
64725-3920	Geodon	ziprasidone mesylate	TYA Pharmaceuticals	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81063	SUPPL	2025-02-06
80946	SUPPL	2025-02-05
67561	SUPPL	2021-05-20
67552	SUPPL	2021-05-19
66067	SUPPL	2021-02-02
65116	SUPPL	2020-11-02
61643	SUPPL	2020-01-24
61634	SUPPL	2020-01-24
56500	SUPPL	2018-11-16
56315	SUPPL	2018-11-06
47419	SUPPL	2017-03-02
47313	SUPPL	2017-02-24
35648	SUPPL	2015-09-14
26203	SUPPL	2015-08-24
35647	SUPPL	2014-12-11
3752	SUPPL	2014-12-11
26202	SUPPL	2013-12-19
13741	SUPPL	2013-12-19
26201	SUPPL	2013-08-16
13740	SUPPL	2013-08-15
26199	SUPPL	2013-07-05
13739	SUPPL	2013-07-05
26200	SUPPL	2013-03-05
35646	SUPPL	2013-03-04
23610	ORIG	2011-12-22
26198	SUPPL	2010-12-07
35645	SUPPL	2010-12-04
26197	SUPPL	2009-08-04
35644	SUPPL	2009-07-21
26196	SUPPL	2008-12-24
3751	SUPPL	2008-08-19
21276	SUPPL	2008-07-30
26195	SUPPL	2008-05-21
35643	SUPPL	2007-10-04
3750	SUPPL	2007-10-04
26194	SUPPL	2007-05-29
13738	SUPPL	2007-05-29
35642	SUPPL	2007-03-07
26193	SUPPL	2007-03-07
35641	SUPPL	2005-08-19
26192	SUPPL	2005-08-19
13737	SUPPL	2005-08-19
3749	SUPPL	2005-08-19
41812	ORIG	2005-04-08
3748	SUPPL	2004-08-25
3747	SUPPL	2003-12-24
26191	ORIG	2002-06-21
13736	ORIG	2002-06-21