Application 210356

Type: ANDA
Sponsor: FRESENIUS KABI USA

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 42.

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
A210356-001	HALOPERIDOL	HALOPERIDOL LACTATE	EQ 5MG BASE/ML	INJECTABLE / INJECTION			2019-07-01

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A210356-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2019-07-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210356-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2019-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210356-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2019-07-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210356-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2019-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210356-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION		2019-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210356-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210356-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210356-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210356-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210356-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210356-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210356-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210356-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210356-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210356-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210356-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210356-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210356-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210356-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210356-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210356-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210356-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210356-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210356-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210356-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210356-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210356-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210356-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210356-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210356-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210356-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210356-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210356-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210356-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210356-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210356-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210356-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210356-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210356-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210356-001	HALOPERIDOL	EQ 5MG BASE/ML	INJECTABLE / INJECTION	AP	2019-07-01	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210356-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210356-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210356-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210356-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210356-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210356-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210356-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210356-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210356-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210356-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210356-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210356-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210356-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210356-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210356-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210356-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210356-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210356-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210356-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210356-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210356-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210356-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210356-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210356-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210356-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210356-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210356-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210356-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210356-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210356-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210356-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210356-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210356-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210356-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210356-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210356-001	AP	1	`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 3 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	ea01b32e-5abe-455d-8813-cef101fa53f1	2025-10-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	2cffe2ad-3dad-479e-a91a-b41c3dd05ce1	2025-10-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	Cardinal Health 107, LLC	8ca14b79-6671-4e44-aa34-6564a92aa197	2025-10-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	Coupler LLC	40187e83-1144-db0e-e063-6394a90a42df	2025-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	REMEDYREPACK INC.	a0751f2e-05ab-4ba9-9bae-7b791bf1a621	2025-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	Mylan Institutional Inc.	ad7d2f17-a4e8-4ebc-9baf-5983ac626782	2025-09-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	Coupler LLC	38f59751-4741-f588-e063-6294a90a6528	2025-07-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	Method Pharmaceuticals, LLC	87f8773b-bf89-4f7e-bff4-8cad117d5776	2025-06-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	490efba9-70f1-46b8-9d62-2f96163e25df	2025-06-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	American Health Packaging	0ac0cc44-3924-447d-9051-f84c44312380	2025-06-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	American Health Packaging	d62617da-c8ad-45da-8915-c59edc5558a5	2025-06-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	Coupler LLC	325d169d-310d-4ada-e063-6294a90afbdd	2025-04-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	Coupler LLC	315899f3-d510-10b0-e063-6294a90a2f3e	2025-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	American Health Packaging	862d9bcd-aaaf-4b10-9013-f696f4cf9581	2025-02-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	Coupler LLC	2ccbc964-a95c-d820-e063-6394a90a4307	2025-01-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	Coupler LLC	2ccc2e26-de98-af81-e063-6394a90a040b	2025-01-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	Major Pharmaceuticals	8a1014d0-d917-40b7-bddd-9ac97df91ef4	2025-01-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	PAI Holdings, LLC dba PAI Pharma	b488c106-f1ee-4b7b-8516-01162fb929f7	2025-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	Mylan Pharmaceuticals Inc.	c559b0b0-4087-d12a-e718-c18ccb6811e6	2025-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol
Haloperidol	HALOPERIDOL	Bryant Ranch Prepack	e8977803-08a2-4ad0-87d5-63d81c98a536	2024-12-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Haloperidol

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
76045-737	Haloperidol	haloperidol lactate	Fresenius Kabi USA, LLC	ANDA	Current
76045-737	Haloperidol	haloperidol lactate	Fresenius Kabi USA, LLC	ANDA	Current
76045-737	Haloperidol	haloperidol lactate	Fresenius Kabi USA, LLC	ANDA	Current
76045-737	Haloperidol	haloperidol lactate	Fresenius Kabi USA, LLC	ANDA	Current
76045-737	Haloperidol	haloperidol lactate	Fresenius Kabi USA, LLC	ANDA	Current