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 2 of 5 · 84 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HALOPERIDOL	HALOPERIDOL	Bryant Ranch Prepack	f6fb9e4c-630b-4f82-8223-f154dd6c17a2	2026-04-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: HALOPERIDOL
HALOPERIDOL	HALOPERIDOL	Bryant Ranch Prepack	42549018-8f15-40b4-ac0a-8b06a2178e46	2026-04-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: HALOPERIDOL
HALOPERIDOL	HALOPERIDOL	Bryant Ranch Prepack	7212f03f-caa0-43bc-aac5-9d8b3c304897	2026-04-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: HALOPERIDOL
Haloperidol	HALOPERIDOL	NCS HealthCare of KY, LLC dba Vangard Labs	8743da03-67f1-4cb0-8159-45141cb5466e	2026-04-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	REMEDYREPACK INC.	a3afd19a-c340-4fad-8ddd-d71242515345	2026-04-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	REMEDYREPACK INC.	22598f07-501b-471a-b512-449d95e2301c	2026-04-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	AiPing Pharmaceutical, Inc	bacc68ed-717b-477a-afa4-c45c182c617b	2026-04-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	Major Pharmaceuticals	e07f02d4-2768-4978-97ee-23ac52d0b846	2026-03-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL LACTATE	REMEDYREPACK INC.	e702b2f0-d464-41c3-977a-d37bb22c0ab0	2026-03-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL LACTATE
Haloperidol	HALOPERIDOL	REMEDYREPACK INC.	eb69959d-5967-41ac-a222-ff4416869dfc	2026-02-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	REMEDYREPACK INC.	b5a6c54c-fb70-4132-90ae-7d75b5e9c9de	2026-02-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
HALOPERIDOL	HALOPERIDOL	Novadoz Pharmaceuticals LLC	3a474e06-fb00-40cb-aa3a-6edad43c2c0a	2026-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: HALOPERIDOL
Haloperidol	HALOPERIDOL	REMEDYREPACK INC.	1e396020-899d-4f51-b71a-4982c503ca4f	2026-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	REMEDYREPACK INC.	58fa9328-b1c7-407c-b215-9887db90cb94	2026-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	Innogenix, Inc.	2c26af24-5ed3-4eb7-8d29-d6a019320a70	2026-01-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
HALOPERIDOL	HALOPERIDOL	Creekwood Pharmaceuticals LLC	9763c044-7430-48f7-bf3e-da1c7c683955	2025-12-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: HALOPERIDOL
Haloperidol	HALOPERIDOL	Advagen Pharma Ltd	8bfdc739-51b4-4914-9a60-923e83762307	2025-12-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	966db55f-3f12-4653-9668-1beff85df0ab	2025-10-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	5f4d945e-97f0-4afc-88d6-9b55ec238686	2025-10-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	9353117e-bd01-441a-b35f-fd1352c5df8c	2025-10-29	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.