Application 015923

Type: NDA
Sponsor: JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HALDOL	HALOPERIDOL LACTATE	INJECTABLE;INJECTION	EQ 5MG BASE/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N015923-001	HALDOL	HALOPERIDOL LACTATE	EQ 5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N015923-001	HALDOL	EQ 5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N015923-001	HALDOL	EQ 5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N015923-001	HALDOL	EQ 5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N015923-001	HALDOL	EQ 5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N015923-001	HALDOL	EQ 5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N015923-001	HALDOL	EQ 5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N015923-001	HALDOL	EQ 5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N015923-001	HALDOL	EQ 5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N015923-001	HALDOL	EQ 5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N015923-001	HALDOL	EQ 5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N015923-001	HALDOL	EQ 5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N015923-001	HALDOL	EQ 5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N015923-001	HALDOL	EQ 5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N015923-001	HALDOL	EQ 5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N015923-001	HALDOL	EQ 5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N015923-001	HALDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N015923-001	HALDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N015923-001	HALDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N015923-001	HALDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N015923-001	HALDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N015923-001	HALDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N015923-001	HALDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N015923-001	HALDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION		RLD, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N015923-001	HALDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N015923-001	HALDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N015923-001	HALDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N015923-001	HALDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N015923-001	HALDOL	EQ 5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N015923-001	HALDOL	EQ 5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N015923-001	HALDOL	EQ 5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N015923-001	HALDOL	EQ 5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N015923-001	HALDOL	EQ 5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N015923-001	HALDOL	EQ 5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N015923-001	HALDOL	EQ 5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N015923-001	HALDOL	EQ 5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N015923-001	HALDOL	EQ 5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N015923-001	HALDOL	EQ 5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N015923-001	HALDOL	EQ 5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N015923-001	HALDOL	EQ 5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N015923-001	HALDOL	EQ 5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD, Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N015923-001	AP	1	`74a2ff9319b5…`
2020-11-12 02:37 UTC	2020-11	N015923-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N015923-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N015923-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N015923-001	AP	1	`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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HALOPERIDOL LACTATE	HALOPERIDOL LACTATE	REMEDYREPACK INC.	4289f7db-e25d-4578-8adf-f0222ae64aa6	2026-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: HALOPERIDOL LACTATE
Haloperidol	HALOPERIDOL LACTATE	Cardinal Health 107, LLC	e2eed126-cb82-42b1-9b48-9cbeb6873b50	2026-06-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: HALOPERIDOL LACTATE
HALOPERIDOL LACTATE	HALOPERIDOL LACTATE	Cardinal Health 107, LLC	7d1a9689-23c8-44ef-a474-8c607e13d794	2026-06-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: HALOPERIDOL LACTATE
Haloperidol	HALOPERIDOL LACTATE	REMEDYREPACK INC.	e702b2f0-d464-41c3-977a-d37bb22c0ab0	2026-03-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: HALOPERIDOL LACTATE
Haloperidol	HALOPERIDOL LACTATE	Hikma Pharmaceuticals USA Inc.	8397a841-f240-4767-9dcd-781e6d3f7c7f	2024-12-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: HALOPERIDOL LACTATE
HALOPERIDOL LACTATE	HALOPERIDOL LACTATE	Mylan Institutional LLC	909259a3-7627-4d1e-91d3-3363b3493599	2024-11-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: HALOPERIDOL LACTATE
Haloperidol	HALOPERIDOL LACTATE	Hikma Pharmaceuticals USA Inc.	ec7a3560-71c3-43f5-bc6c-d51eadfd2aa1	2022-07-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: HALOPERIDOL LACTATE
Haloperidol	HALOPERIDOL LACTATE	Fresenius Kabi USA, LLC	b1ad2abd-a9d6-44e3-957b-36a73260f4f5	2022-01-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: HALOPERIDOL LACTATE
HALOPERIDOL	HALOPERIDOL LACTATE	HF Acquisition Co LLC, DBA HealthFirst	beb6d1cf-98db-d0a5-e053-2995a90ace90	2021-03-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: HALOPERIDOL LACTATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10147-0911	Haloperidol	Haloperidol	Patriot Pharmaceuticals LLC	NDA AUTHORIZED GENERIC	Current
10147-0911	Haloperidol	Haloperidol	Patriot Pharmaceuticals LLC	NDA AUTHORIZED GENERIC	Current
10147-0911	Haloperidol	Haloperidol	Patriot Pharmaceuticals LLC	NDA AUTHORIZED GENERIC	Current
10147-0911	Haloperidol	Haloperidol	Patriot Pharmaceuticals LLC	NDA AUTHORIZED GENERIC	Current
50458-255	Haldol	Haloperidol	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-255	Haldol	Haloperidol	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-255	Haldol	Haloperidol	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-255	Haldol	Haloperidol	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-255	Haldol	Haloperidol	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-255	Haldol	Haloperidol	Janssen Pharmaceuticals, Inc.	NDA	Current
64725-0911	Haloperidol	Haloperidol	TYA Pharmaceuticals	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
65283	SUPPL	2020-11-19
65265	SUPPL	2020-11-18
65264	SUPPL	2020-11-18
57960	SUPPL	2019-03-12
57954	SUPPL	2019-03-12
50645	SUPPL	2017-12-08
50628	SUPPL	2017-12-07
47375	SUPPL	2017-03-02
47358	SUPPL	2017-02-27
10867	SUPPL	2016-05-20
409	SUPPL	2016-05-20
10866	SUPPL	2015-05-29
408	SUPPL	2015-05-28
12961	SUPPL	2013-05-07
10862	SUPPL	2011-08-16
403	SUPPL	2011-08-15
407	SUPPL	2011-03-07
10865	SUPPL	2011-03-04
406	SUPPL	2010-12-06
33135	SUPPL	2010-12-04
10864	SUPPL	2009-08-14
405	SUPPL	2009-08-04
10863	SUPPL	2008-08-29
12960	SUPPL	2008-08-19
33134	SUPPL	2008-06-05
404	SUPPL	2008-05-14
12959	SUPPL	2007-09-25
40701	SUPPL	2007-07-06
402	SUPPL	2007-05-09
10861	SUPPL	2007-05-07