Application 018701

Type: NDA
Sponsor: JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HALDOL	HALOPERIDOL DECANOATE	INJECTABLE;INJECTION	EQ 50MG BASE/ML	Yes	Yes
002	HALDOL	HALOPERIDOL DECANOATE	INJECTABLE;INJECTION	EQ 100MG BASE/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018701-001	HALDOL	HALOPERIDOL DECANOATE	EQ 50MG BASE/ML	INJECTABLE / INJECTION		RLD	1986-01-14
N018701-002	HALDOL	HALOPERIDOL DECANOATE	EQ 100MG BASE/ML	INJECTABLE / INJECTION		RLD	1997-01-31

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 3 · 84 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
2026-08-18 06:07:40	2026-07	N018701-001	HALDOL	EQ 50MG BASE/ML	INJECTABLE / INJECTION		RLD	1986-01-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018701-002	HALDOL	EQ 100MG BASE/ML	INJECTABLE / INJECTION		RLD	1997-01-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018701-001	HALDOL	EQ 50MG BASE/ML	INJECTABLE / INJECTION		RLD	1986-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018701-002	HALDOL	EQ 100MG BASE/ML	INJECTABLE / INJECTION		RLD	1997-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018701-001	HALDOL	EQ 50MG BASE/ML	INJECTABLE / INJECTION		RLD	1986-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018701-002	HALDOL	EQ 100MG BASE/ML	INJECTABLE / INJECTION		RLD	1997-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018701-001	HALDOL	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	RLD, RS	1986-01-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018701-002	HALDOL	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	RLD, RS	1997-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018701-001	HALDOL	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	RLD, RS	1986-01-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018701-002	HALDOL	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	RLD, RS	1997-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018701-001	HALDOL	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	RLD, RS	1986-01-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018701-002	HALDOL	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	RLD, RS	1997-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018701-001	HALDOL	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	RLD, RS	1986-01-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018701-002	HALDOL	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	RLD, RS	1997-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018701-001	HALDOL	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	RLD, RS	1986-01-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018701-002	HALDOL	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	RLD, RS	1997-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018701-001	HALDOL	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	RLD, RS	1986-01-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018701-002	HALDOL	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	RLD, RS	1997-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018701-001	HALDOL	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	RLD, RS	1986-01-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018701-002	HALDOL	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	RLD, RS	1997-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018701-001	HALDOL	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	RLD, RS	1986-01-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018701-002	HALDOL	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	RLD, RS	1997-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018701-001	HALDOL	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	RLD, RS	1986-01-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018701-002	HALDOL	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	RLD, RS	1997-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018701-001	HALDOL	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	RLD, RS	1986-01-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018701-002	HALDOL	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	RLD, RS	1997-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018701-001	HALDOL	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	RLD, RS	1986-01-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018701-002	HALDOL	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	RLD, RS	1997-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018701-001	HALDOL	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	RLD, RS	1986-01-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018701-002	HALDOL	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	RLD, RS	1997-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018701-001	HALDOL	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	RLD, RS	1986-01-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018701-002	HALDOL	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	RLD, RS	1997-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018701-001	HALDOL	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	RLD, RS	1986-01-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018701-002	HALDOL	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	RLD, RS	1997-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018701-001	HALDOL	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	RLD, RS	1986-01-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018701-002	HALDOL	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	RLD, RS	1997-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018701-001	HALDOL	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	RLD, RS	1986-01-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018701-002	HALDOL	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	RLD, RS	1997-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018701-001	HALDOL	EQ 50MG BASE/ML	INJECTABLE / INJECTION	AO	RLD, RS	1986-01-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018701-002	HALDOL	EQ 100MG BASE/ML	INJECTABLE / INJECTION	AO	RLD, RS	1997-01-31	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	N018701-001	AO	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018701-002	AO	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018701-001	AO	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018701-002	AO	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018701-001	AO	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018701-002	AO	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018701-001	AO	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018701-002	AO	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018701-001	AO	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018701-002	AO	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018701-001	AO	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018701-002	AO	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018701-001	AO	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018701-002	AO	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018701-001	AO	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018701-002	AO	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018701-001	AO	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018701-002	AO	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018701-001	AO	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018701-002	AO	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018701-001	AO	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018701-002	AO	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018701-001	AO	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018701-002	AO	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018701-001	AO	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018701-002	AO	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018701-001	AO	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018701-002	AO	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018701-001	AO	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018701-002	AO	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018701-001	AO	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018701-002	AO	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018701-001	AO	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018701-002	AO	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018701-001	AO	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018701-002	AO	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018701-001	AO	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018701-002	AO	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018701-001	AO	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N018701-002	AO	1	`5aa47cf7b7d7…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Haldol Decanoate	HALOPERIDOL DECANOATE	Janssen Pharmaceuticals, Inc.	af0159a8-dff5-449a-aa2b-a0c430081e21	2025-11-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018701 application number: NDA018701 ndc (product): 50458-253 ndc (product): 50458-254
Haloperidol Decanoate	HALOPERIDOL DECANOATE	Patriot Pharmaceuticals LLC	9f0f42a8-5f7c-4be7-93ef-3ec225502cc6	2025-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 018701 application number: NDA018701 ndc (product): 10147-0921 ndc (product): 10147-0922

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10147-0921	Haloperidol Decanoate	Haloperidol Decanoate	Patriot Pharmaceuticals LLC	NDA AUTHORIZED GENERIC	Current
10147-0921	Haloperidol Decanoate	Haloperidol Decanoate	Patriot Pharmaceuticals LLC	NDA AUTHORIZED GENERIC	Current
10147-0921	Haloperidol Decanoate	Haloperidol Decanoate	Patriot Pharmaceuticals LLC	NDA AUTHORIZED GENERIC	Current
10147-0921	Haloperidol Decanoate	Haloperidol Decanoate	Patriot Pharmaceuticals LLC	NDA AUTHORIZED GENERIC	Current
10147-0922	Haloperidol Decanoate	Haloperidol Decanoate	Patriot Pharmaceuticals LLC	NDA AUTHORIZED GENERIC	Current
10147-0922	Haloperidol Decanoate	Haloperidol Decanoate	Patriot Pharmaceuticals LLC	NDA AUTHORIZED GENERIC	Current
10147-0922	Haloperidol Decanoate	Haloperidol Decanoate	Patriot Pharmaceuticals LLC	NDA AUTHORIZED GENERIC	Current
10147-0922	Haloperidol Decanoate	Haloperidol Decanoate	Patriot Pharmaceuticals LLC	NDA AUTHORIZED GENERIC	Current
50458-253	Haldol Decanoate	Haloperidol Decanoate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-253	Haldol Decanoate	Haloperidol Decanoate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-253	Haldol Decanoate	Haloperidol Decanoate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-253	Haldol Decanoate	Haloperidol Decanoate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-254	Haldol Decanoate	Haloperidol Decanoate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-254	Haldol Decanoate	Haloperidol Decanoate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-254	Haldol Decanoate	Haloperidol Decanoate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-254	Haldol Decanoate	Haloperidol Decanoate	Janssen Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84038	SUPPL	2025-11-03
84032	SUPPL	2025-10-31
81147	SUPPL	2025-02-07
80933	SUPPL	2025-02-05
65284	SUPPL	2020-11-19
65267	SUPPL	2020-11-18
65266	SUPPL	2020-11-18
57961	SUPPL	2019-03-12
57955	SUPPL	2019-03-12
50630	SUPPL	2017-12-07
50629	SUPPL	2017-12-07
47357	SUPPL	2017-03-02
47356	SUPPL	2017-02-27
15096	SUPPL	2016-05-20
11281	SUPPL	2016-05-20
1029	SUPPL	2013-05-07
11279	SUPPL	2011-08-16
1025	SUPPL	2011-08-15
15095	SUPPL	2011-03-07
33561	SUPPL	2011-03-04
1028	SUPPL	2010-12-06
33560	SUPPL	2010-12-04
1027	SUPPL	2009-08-04
11280	SUPPL	2009-07-23
33559	SUPPL	2008-08-29
1026	SUPPL	2008-08-19
33558	SUPPL	2008-06-05
15094	SUPPL	2008-05-14
15093	SUPPL	2007-09-25
20149	SUPPL	2007-07-06
15092	SUPPL	2007-05-09
33557	SUPPL	2007-05-07