Application 076464

Type: ANDA
Sponsor: FOSUN PHARMA

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 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
A076464-001	HALOPERIDOL	HALOPERIDOL LACTATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION			2004-09-29

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076464-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2004-09-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076464-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2004-09-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076464-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2004-09-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076464-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2004-09-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076464-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2004-09-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076464-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2004-09-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076464-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2004-09-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076464-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2004-09-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076464-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2004-09-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076464-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2004-09-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076464-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2004-09-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076464-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2004-09-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076464-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2004-09-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076464-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2004-09-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076464-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2004-09-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076464-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2004-09-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076464-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2004-09-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076464-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2004-09-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076464-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2004-09-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076464-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2004-09-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076464-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2004-09-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076464-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2004-09-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076464-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2004-09-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076464-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2004-09-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076464-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2004-09-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076464-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2004-09-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076464-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2004-09-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076464-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2004-09-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076464-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2004-09-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076464-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2004-09-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076464-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2004-09-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076464-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2004-09-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076464-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2004-09-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076464-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2004-09-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076464-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2004-09-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076464-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2004-09-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076464-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2004-09-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076464-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2004-09-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076464-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2004-09-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076464-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	2004-09-29	`cb3db0bc1861…`

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 5 · 82 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	REMEDYREPACK INC.	746f3ab9-9e6e-4ce8-9384-0c7a57de8007	2026-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	Unit Dose Solutions, Inc.	54ee5fa9-e346-a1d0-e063-6294a90aef83	2026-06-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL LACTATE	Cardinal Health 107, LLC	e2eed126-cb82-42b1-9b48-9cbeb6873b50	2026-06-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol generic name: HALOPERIDOL LACTATE
Haloperidol	HALOPERIDOL	Safecor Health, LLC	9be08519-b3b5-4b9d-ae4c-bb7e68f19ede	2026-06-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
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	Cardinal Health 107, LLC	eaabdc53-366f-4dc2-b9c7-0d70f1bbb6f9	2026-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	Coupler LLC	50b0ea2f-0a54-7b49-e063-6394a90abcc4	2026-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	Coupler LLC	26aa869a-25e8-0dd5-e063-6394a90a0aba	2026-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	Coupler LLC	509e5424-1323-c841-e063-6294a90a2714	2026-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	REMEDYREPACK INC.	861c7b75-572c-48c2-adf9-1ca3fc3db19b	2026-04-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	PD-Rx Pharmaceuticals, Inc.	533b0b4c-cbd6-4ec0-a333-8b04b5b43a1d	2026-04-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
HALOPERIDOL	HALOPERIDOL	Bryant Ranch Prepack	57d77858-758c-41ce-a47c-ca42c4e88859	2026-04-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: HALOPERIDOL
HALOPERIDOL	HALOPERIDOL	Bryant Ranch Prepack	f6f6f2ed-33a5-4139-b2f1-ce446814e597	2026-04-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: HALOPERIDOL
HALOPERIDOL	HALOPERIDOL	Bryant Ranch Prepack	7666e56f-9eef-4343-8a76-60613c4ca57f	2026-04-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: HALOPERIDOL
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

Application 076464

Related Records#

Application Products#

Orange Book products#

Observed Orange Book product history#

openFDA label cross-check#