Application 021483

Type: NDA
Sponsor: PFIZER INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GEODON	ZIPRASIDONE HYDROCHLORIDE	SUSPENSION;ORAL	EQ 10MG BASE/ML	No	No

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
N021483-001	GEODON	ZIPRASIDONE HYDROCHLORIDE	EQ 10MG BASE/ML	SUSPENSION / ORAL			2006-03-29

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021483-001	GEODON	EQ 10MG BASE/ML	SUSPENSION / ORAL	2006-03-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021483-001	GEODON	EQ 10MG BASE/ML	SUSPENSION / ORAL	2006-03-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021483-001	GEODON	EQ 10MG BASE/ML	SUSPENSION / ORAL	2006-03-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021483-001	GEODON	EQ 10MG BASE/ML	SUSPENSION / ORAL	2006-03-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021483-001	GEODON	EQ 10MG BASE/ML	SUSPENSION / ORAL	2006-03-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021483-001	GEODON	EQ 10MG BASE/ML	SUSPENSION / ORAL	2006-03-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021483-001	GEODON	EQ 10MG BASE/ML	SUSPENSION / ORAL	2006-03-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021483-001	GEODON	EQ 10MG BASE/ML	SUSPENSION / ORAL	2006-03-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021483-001	GEODON	EQ 10MG BASE/ML	SUSPENSION / ORAL	2006-03-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021483-001	GEODON	EQ 10MG BASE/ML	SUSPENSION / ORAL	2006-03-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021483-001	GEODON	EQ 10MG BASE/ML	SUSPENSION / ORAL	2006-03-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021483-001	GEODON	EQ 10MG BASE/ML	SUSPENSION / ORAL	2006-03-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021483-001	GEODON	EQ 10MG BASE/ML	SUSPENSION / ORAL	2006-03-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021483-001	GEODON	EQ 10MG BASE/ML	SUSPENSION / ORAL	2006-03-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021483-001	GEODON	EQ 10MG BASE/ML	SUSPENSION / ORAL	2006-03-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021483-001	GEODON	EQ 10MG BASE/ML	SUSPENSION / ORAL	2006-03-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021483-001	GEODON	EQ 10MG BASE/ML	SUSPENSION / ORAL	2006-03-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021483-001	GEODON	EQ 10MG BASE/ML	SUSPENSION / ORAL	2006-03-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021483-001	GEODON	EQ 10MG BASE/ML	SUSPENSION / ORAL	2006-03-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021483-001	GEODON	EQ 10MG BASE/ML	SUSPENSION / ORAL	2006-03-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021483-001	GEODON	EQ 10MG BASE/ML	SUSPENSION / ORAL	2006-03-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021483-001	GEODON	EQ 10MG BASE/ML	SUSPENSION / ORAL	2006-03-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021483-001	GEODON	EQ 10MG BASE/ML	SUSPENSION / ORAL	2006-03-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021483-001	GEODON	EQ 10MG BASE/ML	SUSPENSION / ORAL	2006-03-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021483-001	GEODON	EQ 10MG BASE/ML	SUSPENSION / ORAL	2006-03-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021483-001	GEODON	EQ 10MG BASE/ML	SUSPENSION / ORAL	2006-03-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021483-001	GEODON	EQ 10MG BASE/ML	SUSPENSION / ORAL	2006-03-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021483-001	GEODON	EQ 10MG BASE/ML	SUSPENSION / ORAL	2006-03-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021483-001	GEODON	EQ 10MG BASE/ML	SUSPENSION / ORAL	2006-03-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021483-001	GEODON	EQ 10MG BASE/ML	SUSPENSION / ORAL	2006-03-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021483-001	GEODON	EQ 10MG BASE/ML	SUSPENSION / ORAL	2006-03-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021483-001	GEODON	EQ 10MG BASE/ML	SUSPENSION / ORAL	2006-03-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021483-001	GEODON	EQ 10MG BASE/ML	SUSPENSION / ORAL	2006-03-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021483-001	GEODON	EQ 10MG BASE/ML	SUSPENSION / ORAL	2006-03-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021483-001	GEODON	EQ 10MG BASE/ML	SUSPENSION / ORAL	2006-03-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021483-001	GEODON	EQ 10MG BASE/ML	SUSPENSION / ORAL	2006-03-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021483-001	GEODON	EQ 10MG BASE/ML	SUSPENSION / ORAL	2006-03-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021483-001	GEODON	EQ 10MG BASE/ML	SUSPENSION / ORAL	2006-03-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021483-001	GEODON	EQ 10MG BASE/ML	SUSPENSION / ORAL	2006-03-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021483-001	GEODON	EQ 10MG BASE/ML	SUSPENSION / ORAL	2006-03-29	`f41ea6bd6efb…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021483-001	6150366	2019-05-27	U-719	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021483-001	7175855	2020-05-18		Drug product	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021483-001	7175855	2020-05-18		Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021483-001	7175855	2020-05-18		Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021483-001	6150366	2019-05-27	U-719	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021483-001	7175855	2020-05-18		Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021483-001	6150366	2019-05-27	U-719	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021483-001	7175855	2020-05-18		Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021483-001	6150366	2019-05-27	U-719	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021483-001	7175855	2020-05-18		Drug product	`ea99ee380514…`

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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ziprasidone hydrochloride	ZIPRASIDONE HYDROCHLORIDE	Bryant Ranch Prepack	5d576819-cd14-4a61-8a2f-6b90d8eac07e	2026-07-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIPRASIDONE HYDROCHLORIDE
Ziprasidone Hydrochloride	ZIPRASIDONE HYDROCHLORIDE	REMEDYREPACK INC.	c9f8f635-cf3f-4c42-8bd1-45bbe19bf97e	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIPRASIDONE HYDROCHLORIDE
Ziprasidone Hydrochloride	ZIPRASIDONE HYDROCHLORIDE	REMEDYREPACK INC.	a66a0b25-673c-4a3d-b923-5f65a02b8ff0	2026-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIPRASIDONE HYDROCHLORIDE
Ziprasidone Hydrochloride	ZIPRASIDONE HYDROCHLORIDE	REMEDYREPACK INC.	4e7e2d5d-8ea8-4c25-a500-f4794542fda2	2026-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIPRASIDONE HYDROCHLORIDE
ziprasidone hydrochloride	ZIPRASIDONE HYDROCHLORIDE	REMEDYREPACK INC.	56370be6-42a2-4962-acdc-22b7c6e0e7fe	2026-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIPRASIDONE HYDROCHLORIDE
ziprasidone hydrochloride	ZIPRASIDONE HYDROCHLORIDE	Bryant Ranch Prepack	14191e0d-8219-4f6e-b808-09c4804a8262	2026-03-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIPRASIDONE HYDROCHLORIDE
Ziprasidone Hydrochloride	ZIPRASIDONE HYDROCHLORIDE	Bryant Ranch Prepack	7c683604-b827-434d-aff3-ee2ed0565cd7	2026-03-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIPRASIDONE HYDROCHLORIDE
Ziprasidone Hydrochloride	ZIPRASIDONE HYDROCHLORIDE	Aurobindo Pharma Limited	cc5e1c44-79e9-45d3-b1e5-b003f550c508	2025-05-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIPRASIDONE HYDROCHLORIDE
Ziprasidone Hydrochloride	ZIPRASIDONE HYDROCHLORIDE	BluePoint Laboratories	c0eb7b4d-0264-4eed-8756-51bba3af82fb	2025-04-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIPRASIDONE HYDROCHLORIDE
ziprasidone hydrochloride	ZIPRASIDONE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	fc9ffbc3-1f16-9265-e053-6294a90acfd2	2025-02-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIPRASIDONE HYDROCHLORIDE
Ziprasidone Hydrochloride	ZIPRASIDONE HYDROCHLORIDE	A-S Medication Solutions	c3797145-cead-4fc4-9711-8b8623bb09f4	2024-11-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIPRASIDONE HYDROCHLORIDE
Ziprasidone Hydrochloride	ZIPRASIDONE HYDROCHLORIDE	Bryant Ranch Prepack	550aca3a-5051-432e-9a3f-a2e53cbd603d	2024-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIPRASIDONE HYDROCHLORIDE
Ziprasidone Hydrochloride	ZIPRASIDONE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	0fcebd61-25b2-d287-e063-6394a90a7b9a	2024-01-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIPRASIDONE HYDROCHLORIDE
Ziprasidone Hydrochloride	ZIPRASIDONE HYDROCHLORIDE	Bryant Ranch Prepack	798631b6-b9d9-44de-9a1a-ae2cee86d531	2023-11-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIPRASIDONE HYDROCHLORIDE
Ziprasidone Hydrochloride	ZIPRASIDONE HYDROCHLORIDE	Bryant Ranch Prepack	fa70291d-8455-40d6-9b73-bf91880f9979	2023-10-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIPRASIDONE HYDROCHLORIDE
ziprasidone hydrochloride	ZIPRASIDONE HYDROCHLORIDE	Bryant Ranch Prepack	48e6e141-66d3-4eab-b0bf-dfd1d44b4832	2023-09-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIPRASIDONE HYDROCHLORIDE
Ziprasidone Hydrochloride	ZIPRASIDONE HYDROCHLORIDE	Macleods Pharmaceuticals Limited	3e0d1436-2e2b-4c34-a9bc-4a6b2ac38af0	2023-02-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ZIPRASIDONE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
47418	SUPPL	2017-03-02
47312	SUPPL	2017-02-24
15574	SUPPL	2015-09-14
5510	SUPPL	2015-08-24
27905	SUPPL	2014-12-11
15573	SUPPL	2014-12-11
5509	SUPPL	2013-08-16
15572	SUPPL	2013-08-15
37045	SUPPL	2013-07-05
27903	SUPPL	2013-07-05
27904	SUPPL	2013-03-05
37046	SUPPL	2013-03-04
27902	SUPPL	2010-12-07
15571	SUPPL	2010-12-04
5508	SUPPL	2009-11-24
15570	SUPPL	2009-09-18
42190	ORIG	2007-06-29
23666	ORIG	2006-04-05
5507	ORIG	2006-04-05