Application 070802

Type: ANDA
Sponsor: SMITH AND NEPHEW

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HALOPERIDOL	HALOPERIDOL LACTATE	INJECTABLE;INJECTION	EQ 5MG 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
A070802-001	HALOPERIDOL	HALOPERIDOL LACTATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION			1987-12-14

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	A070802-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	1987-12-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A070802-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	1987-12-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070802-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	1987-12-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070802-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	1987-12-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070802-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	1987-12-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070802-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	1987-12-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070802-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	1987-12-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070802-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	1987-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070802-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	1987-12-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070802-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	1987-12-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070802-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	1987-12-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070802-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	1987-12-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070802-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	1987-12-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070802-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	1987-12-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070802-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	1987-12-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070802-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	1987-12-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070802-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	1987-12-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070802-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	1987-12-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070802-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	1987-12-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070802-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	1987-12-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A070802-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	1987-12-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A070802-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	1987-12-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070802-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	1987-12-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070802-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	1987-12-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070802-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	1987-12-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070802-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	1987-12-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070802-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	1987-12-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070802-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	1987-12-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070802-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	1987-12-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A070802-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	1987-12-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A070802-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	1987-12-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A070802-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	1987-12-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A070802-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	1987-12-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A070802-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	1987-12-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A070802-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	1987-12-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A070802-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	1987-12-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A070802-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	1987-12-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A070802-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	1987-12-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A070802-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	1987-12-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A070802-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	1987-12-14	`f41ea6bd6efb…`

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 4 of 5 · 84 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Haloperidol	HALOPERIDOL LACTATE	Hikma Pharmaceuticals USA Inc.	8397a841-f240-4767-9dcd-781e6d3f7c7f	2024-12-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL LACTATE
Haloperidol	HALOPERIDOL	Zydus Lifesciences Limited	509d0eb2-b930-4836-9669-dbebf0ac4076	2024-11-30		Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	Lifestar Pharma LLC	00bb61c8-db35-4c04-9ef7-47d447d2496b	2024-11-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	Aurobindo Pharma Limited	bf21633e-f37b-4017-a143-538eb005de2d	2024-11-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
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	Zydus Pharmaceuticals USA Inc.	54502f78-7244-454a-9171-4e73127f1456	2024-11-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	Lannett Company, Inc.	3e44fed0-6132-4881-a9cd-af6156c7af9c	2024-11-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	Marlex Pharmaceuticals, Inc.	e7a61604-741f-2d3b-e053-2995a90a62fc	2024-10-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	d9d0e530-02cd-4631-b3c8-cf6de521fd5b	2024-10-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	df340d75-7387-4084-9d76-167283ee7462	2024-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	d896823a-fb08-4777-a1f1-cef85fc8d96c	2024-04-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	f1c56d0d-87d3-40ef-9578-0d99fbae12fe	2024-04-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	88031df0-90bd-4444-9503-1b4612e3856b	2024-04-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	b9e8f5f2-6d59-4a2c-8ccf-88bb58753f60	2024-04-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	a8e9d675-135c-4b5d-91d0-1ef0d295535c	2024-04-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	f20769bc-98a3-419a-ba36-2e9737050cd9	2024-04-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	33dca652-c60c-44e0-9303-ea55a431fdcd	2024-04-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	c3b35c6c-e339-439a-b75f-dd645e08a959	2024-01-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	1171bd60-7105-4b70-a24c-f2bc8c52a8c0	2024-01-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	a79c12f2-cf98-4337-8b6a-7b9ef2afa9d5	2024-01-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol

Reported adverse events (FAERS/openFDA)#

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